Manufacturing Process Engineer Jobs in Massachusetts
Manufacturing Process Engineer jobs in Massachusetts are in strong and consistent demand, concentrated in the state's aerospace and defense, medical devices, biotechnology, and advanced electronics sectors, with openings at every level from entry-level process technician to senior principal engineer. Greater Boston, the Merrimack Valley corridor around Lowell and Andover, and the Route 128 technology belt account for the heaviest hiring activity, where employers like Raytheon Technologies, Boston Scientific, and Thermo Fisher Scientific maintain large engineering workforces. The most sought-after specialties right now are lean manufacturing, validation engineering for FDA-regulated environments, and automation process design. Find a role that fits below and apply directly.
Find JobsOverview
Open roles19
Top employerBiogen
Top cityCambridge, MA
Cities hiring12
Work type78% On-site
Top industryManufacturing
Showing 5 of 19+ Manufacturing Process Engineer jobs
Sr. Process Engineer - Assay Manufacturing
We won't show you this job again
Added 1d ago
Quanterix
Sr. Process Engineer - Assay Manufacturing
Billerica, Massachusetts
Added 1d ago
C
Manufacturing Engineer – Equipment, Process & Quality
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C
Added 1d ago
Crusader Paper Company, Inc.
Manufacturing Engineer – Equipment, Process & Quality
North Andover, Massachusetts
Added 1d ago
Senior Manufacturing Engineer – Process & NPI
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Added 1d ago
Saraca Solutions Inc.
Senior Manufacturing Engineer – Process & NPI
Devens, Massachusetts
Added 1d ago
Principal Process Engineer (SMT Manufacturing)
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Added 2d ago
Draper
Principal Process Engineer (SMT Manufacturing)
Cambridge, Massachusetts
Added 2d ago
Associate Director, Manufacturing Process and Technical Quality Assurance Cell and Genetic Therapies - VCGT
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Added 6d ago
Vertex Pharmaceuticals
Associate Director, Manufacturing Process and Technical Quality Assurance Cell and Genetic Therapies - VCGT
Boston, Massachusetts
Added 6d ago
Added 1d ago
Sr. Process Engineer - Assay Manufacturing
Quanterix·Billerica, Massachusetts
Job functions:
$100k - $120k/yr
Master's degree
201-500 employees
Job Description
Sr. Process Engineer - Assay Manufacturing
Billerica, MA
Quanterix is a global leader in ultra-sensitive biomarker detection, enabling breakthroughs in disease research, diagnostics, and drug development. Its proprietary Simoa® technology delivers industry-leading sensitivity, allowing researchers to detect and quantify biomarkers in blood and other fluids at concentrations far below traditional limits. With more than 3,400 peer-reviewed publications, Quanterix has been a trusted partner to the scientific community for nearly two decades. In 2025, Quanterix acquired Akoya Biosciences, The Spatial Biology Company®, adding multiplexed tissue imaging with single-cell resolution to its portfolio. Together, the combined company offers a uniquely integrated platform that connects biology across blood and tissue—advancing precision medicine from discovery to diagnostics.
ROLE SUMMARY:
We are seeking a highly skilled Sr. Process Engineer - Assay Manufacturing to lead the development, scale-up, and optimization of our diagnostic assay manufacturing lines. The ideal candidate will bridge the gap between R&D and commercial production, ensuring that all manufacturing processes are robust, scalable, and fully compliant with cGMP and ISO 13485 standards. You will be responsible for troubleshooting complex technical issues, implementing automation, and driving continuous improvement to ensure the highest quality of our diagnostic products.
WHAT YOU’LL DO:
- Process Development & Scale-Up: Design, develop, and validate manufacturing processes for complex biological assays, moving products from R&D prototypes to full-scale commercial production.
- cGMP Compliance: Ensure all manufacturing activities, equipment, and documentation strictly adhere to current Good Manufacturing Practices (cGMP), FDA regulations, and ISO standards.
- Equipment Validation (IQ/OQ/PQ): Lead the installation, operational, and performance qualification of automated liquid handlers, plate washers, and other specialized assay manufacturing equipment.
- Technical Troubleshooting: Act as the subject matter expert (SME) for root-cause analysis of process deviations and yield excursions. Implement effective Corrective and Preventive Actions (CAPA).
- Documentation: Author and review Standard Operating Procedures (SOPs), Batch Records, Work Instructions, and Process Validation protocols/reports.
- Continuous Improvement: Identify opportunities for cost reduction and efficiency gains through Lean Manufacturing, Six Sigma methodologies, and the integration of new technologies or automation.
- Cross-Functional Collaboration: Work closely with R&D, Quality Assurance, and Supply Chain to ensure seamless technology transfers and product launches
BASIC QUALIFICATIONS:
- Education: Bachelor’s degree in Chemical Engineering, Bioengineering, Biotechnology, or a related scientific discipline. (Master’s preferred).
- Experience: Minimum 8 years of experience in a process engineering role within a cGMP-regulated environment (e.g., IVD, medical device, or pharmaceutical industry).
- Regulatory Knowledge: Deep familiarity with FDA 21 CFR Part 820 and/or ISO 13485 requirements.
PREFERRED QUALIFICATIONS:
- Direct experience with assay chemistry, reagent formulation, or diagnostic kit assembly
- Hands-on experience with automated manufacturing platforms and liquid handling systems
- Strong understanding of Statistical Process Control (SPC) and Design of Experiments (DoE).
- Experience with Six Sigma or Lean Manufacturing certification (Green/Black Belt).
- Proficiency in statistical software such as Minitab or JMP.
- Background in lyophilization processes or coating technologies.
- Strong project management skills and the ability to lead cross-functional teams.
EXPECTATIONS, COMPETENCIES, SKILLS & ABILITIES:
- Strong judgment, accountability, and attention to detail in a regulated manufacturing environment.
- Effective communication and collaboration across technical and cross-functional teams.
- Strong problem-solving and decision-making skills with the ability to assess risk and recommend practical solutions.
- Ability to manage multiple priorities, adapt to changing business needs, and meet deadlines.
- Professionalism, sound judgment, and the ability to handle sensitive information with discretion.
- Continuous learning mindset with a focus on quality, process improvement, and operational excellence.
- Must be able to work in a cleanroom environment (ISO 7/8).
- Occasional lifting of equipment (up to 25 lbs) may be required.
- Adherence to strict gowning and safety protocols is mandatory.
- Work location: Billerica, MA (Onsite 5 days)
- Travel 10%
WHY YOU’LL LIKE WORKING WITH US:
Our Technology:
From discovery to diagnostics, Quanterix’s ultrasensitive biomarker detection is fueling breakthroughs only made possible through its unparalleled sensitivity and flexibility. Simoa® technology has delivered the gold standard for earlier biomarker detection in blood, serum or plasma, with the ability to quantify proteins that are far lower than the Level of Quantification (LoQ). Our industry-leading precision instruments, digital immunoassay technology and CLIA-certified Accelerator laboratory have supported research that advances disease understanding and management in neurology, oncology, immunology, cardiology, and infectious disease.
Akoya Biosciences, a Quanterix company, is The Spatial Biology Company®—bringing tissue context to life through high-resolution, single-cell imaging. Akoya’s spatial phenotyping platforms help researchers visualize and measure how cells organize and interact within tissue to influence disease progression and therapeutic response. From discovery through clinical research, Akoya offers a full continuum of solutions, including PhenoCycler®, PhenoImager® Fusion and HT, and PhenoCode™ Panels. As part of Quanterix, Akoya complements a leading portfolio of ultra-sensitive biomarker detection technologies, together enabling a more complete view of biology and disease across both tissue and blood.
Our Commitment to Employees:
At Quanterix, our values are based on: Team, Innovation, Customer and Owner.
Team: Challenge assumptions, not the person. Respect diversity of thought and hold ourselves to lofty standards
Innovation: Stay curious, experiment, create and change
Customer: Prioritize and celebrate these pioneers by doing our best to deliver on commitments
Owner: Act with high integrity and in the best interest of Quanterix. Take measured risks and learn from their success and failures.
We reward and recognize our employees by offering competitive compensation and a 401k plan with employer match, as well as competitive health, dental, and vision benefits for employees and their dependents. We also offer an unlimited vacation policy to all exempt employees, and a generous PTO policy for non-exempt employees. All employees are eligible for equity, employee stock purchase plan, a performance bonus, and 1:1 financial counseling/planning. We also offer Tuition Assistance. We have a free, state-of-the-art onsite fitness center for all employees. To keep you fueled up, we provide onsite employees free snacks and drinks every day!
DIVERSE & INCLUSIVE WORKPLACE:
Quanterix is committed to a Diverse and Inclusive workplace. We strive to recruit candidates who will bring inclusive mindsets and contribute to our values.
Quanterix is an Equal Opportunity Employer and does not discriminate based on race, national origin, gender, gender identity, sexual orientation, protected veteran status, disability, age, or other legally protected status. Quanterix will make reasonable accommodations for qualified individuals with known disabilities, in accordance with applicable law.
Quanterix
Sr. Process Engineer - Assay Manufacturing
Billerica, Massachusetts
Added 1d ago201-500 employees
Job functions:
$100k - $120k/yr
Master's degree
Job Description
Sr. Process Engineer - Assay Manufacturing
Billerica, MA
Quanterix is a global leader in ultra-sensitive biomarker detection, enabling breakthroughs in disease research, diagnostics, and drug development. Its proprietary Simoa® technology delivers industry-leading sensitivity, allowing researchers to detect and quantify biomarkers in blood and other fluids at concentrations far below traditional limits. With more than 3,400 peer-reviewed publications, Quanterix has been a trusted partner to the scientific community for nearly two decades. In 2025, Quanterix acquired Akoya Biosciences, The Spatial Biology Company®, adding multiplexed tissue imaging with single-cell resolution to its portfolio. Together, the combined company offers a uniquely integrated platform that connects biology across blood and tissue—advancing precision medicine from discovery to diagnostics.
ROLE SUMMARY:
We are seeking a highly skilled Sr. Process Engineer - Assay Manufacturing to lead the development, scale-up, and optimization of our diagnostic assay manufacturing lines. The ideal candidate will bridge the gap between R&D and commercial production, ensuring that all manufacturing processes are robust, scalable, and fully compliant with cGMP and ISO 13485 standards. You will be responsible for troubleshooting complex technical issues, implementing automation, and driving continuous improvement to ensure the highest quality of our diagnostic products.
WHAT YOU’LL DO:
- Process Development & Scale-Up: Design, develop, and validate manufacturing processes for complex biological assays, moving products from R&D prototypes to full-scale commercial production.
- cGMP Compliance: Ensure all manufacturing activities, equipment, and documentation strictly adhere to current Good Manufacturing Practices (cGMP), FDA regulations, and ISO standards.
- Equipment Validation (IQ/OQ/PQ): Lead the installation, operational, and performance qualification of automated liquid handlers, plate washers, and other specialized assay manufacturing equipment.
- Technical Troubleshooting: Act as the subject matter expert (SME) for root-cause analysis of process deviations and yield excursions. Implement effective Corrective and Preventive Actions (CAPA).
- Documentation: Author and review Standard Operating Procedures (SOPs), Batch Records, Work Instructions, and Process Validation protocols/reports.
- Continuous Improvement: Identify opportunities for cost reduction and efficiency gains through Lean Manufacturing, Six Sigma methodologies, and the integration of new technologies or automation.
- Cross-Functional Collaboration: Work closely with R&D, Quality Assurance, and Supply Chain to ensure seamless technology transfers and product launches
BASIC QUALIFICATIONS:
- Education: Bachelor’s degree in Chemical Engineering, Bioengineering, Biotechnology, or a related scientific discipline. (Master’s preferred).
- Experience: Minimum 8 years of experience in a process engineering role within a cGMP-regulated environment (e.g., IVD, medical device, or pharmaceutical industry).
- Regulatory Knowledge: Deep familiarity with FDA 21 CFR Part 820 and/or ISO 13485 requirements.
PREFERRED QUALIFICATIONS:
- Direct experience with assay chemistry, reagent formulation, or diagnostic kit assembly
- Hands-on experience with automated manufacturing platforms and liquid handling systems
- Strong understanding of Statistical Process Control (SPC) and Design of Experiments (DoE).
- Experience with Six Sigma or Lean Manufacturing certification (Green/Black Belt).
- Proficiency in statistical software such as Minitab or JMP.
- Background in lyophilization processes or coating technologies.
- Strong project management skills and the ability to lead cross-functional teams.
EXPECTATIONS, COMPETENCIES, SKILLS & ABILITIES:
- Strong judgment, accountability, and attention to detail in a regulated manufacturing environment.
- Effective communication and collaboration across technical and cross-functional teams.
- Strong problem-solving and decision-making skills with the ability to assess risk and recommend practical solutions.
- Ability to manage multiple priorities, adapt to changing business needs, and meet deadlines.
- Professionalism, sound judgment, and the ability to handle sensitive information with discretion.
- Continuous learning mindset with a focus on quality, process improvement, and operational excellence.
- Must be able to work in a cleanroom environment (ISO 7/8).
- Occasional lifting of equipment (up to 25 lbs) may be required.
- Adherence to strict gowning and safety protocols is mandatory.
- Work location: Billerica, MA (Onsite 5 days)
- Travel 10%
WHY YOU’LL LIKE WORKING WITH US:
Our Technology:
From discovery to diagnostics, Quanterix’s ultrasensitive biomarker detection is fueling breakthroughs only made possible through its unparalleled sensitivity and flexibility. Simoa® technology has delivered the gold standard for earlier biomarker detection in blood, serum or plasma, with the ability to quantify proteins that are far lower than the Level of Quantification (LoQ). Our industry-leading precision instruments, digital immunoassay technology and CLIA-certified Accelerator laboratory have supported research that advances disease understanding and management in neurology, oncology, immunology, cardiology, and infectious disease.
Akoya Biosciences, a Quanterix company, is The Spatial Biology Company®—bringing tissue context to life through high-resolution, single-cell imaging. Akoya’s spatial phenotyping platforms help researchers visualize and measure how cells organize and interact within tissue to influence disease progression and therapeutic response. From discovery through clinical research, Akoya offers a full continuum of solutions, including PhenoCycler®, PhenoImager® Fusion and HT, and PhenoCode™ Panels. As part of Quanterix, Akoya complements a leading portfolio of ultra-sensitive biomarker detection technologies, together enabling a more complete view of biology and disease across both tissue and blood.
Our Commitment to Employees:
At Quanterix, our values are based on: Team, Innovation, Customer and Owner.
Team: Challenge assumptions, not the person. Respect diversity of thought and hold ourselves to lofty standards
Innovation: Stay curious, experiment, create and change
Customer: Prioritize and celebrate these pioneers by doing our best to deliver on commitments
Owner: Act with high integrity and in the best interest of Quanterix. Take measured risks and learn from their success and failures.
We reward and recognize our employees by offering competitive compensation and a 401k plan with employer match, as well as competitive health, dental, and vision benefits for employees and their dependents. We also offer an unlimited vacation policy to all exempt employees, and a generous PTO policy for non-exempt employees. All employees are eligible for equity, employee stock purchase plan, a performance bonus, and 1:1 financial counseling/planning. We also offer Tuition Assistance. We have a free, state-of-the-art onsite fitness center for all employees. To keep you fueled up, we provide onsite employees free snacks and drinks every day!
DIVERSE & INCLUSIVE WORKPLACE:
Quanterix is committed to a Diverse and Inclusive workplace. We strive to recruit candidates who will bring inclusive mindsets and contribute to our values.
Quanterix is an Equal Opportunity Employer and does not discriminate based on race, national origin, gender, gender identity, sexual orientation, protected veteran status, disability, age, or other legally protected status. Quanterix will make reasonable accommodations for qualified individuals with known disabilities, in accordance with applicable law.
See All 19 Manufacturing Process Engineer Jobs in Massachusetts
Find roles in Massachusetts that match your experience and apply in just a few clicks.
Find JobsManufacturing Process Engineer Jobs by City in Massachusetts
Where Massachusetts roles are concentrated, by current openings.
Cambridge
5 jobsDevens
3 jobsOrange
2 jobsBoston
1 jobWaltham
1 jobWebster
1 jobWestford
1 jobBillerica
1 jobLexington
1 jobStoughton
1 jobSomerville
1 jobNorth Andover
1 jobManufacturing Process Engineer Job Market in Massachusetts
A snapshot from current Massachusetts openings, updated as new roles post.
Who's Hiring
Top Industries Hiring
- Manufacturing
- Healthcare & Medical Services
- Science & Research
- Biotechnology & Pharmaceuticals
What Massachusetts Employers Look For
The qualifications that appear most often in manufacturing process engineer jobs across Massachusetts.
- Bachelor's degree in mechanical, industrial, or manufacturing engineering from an accredited program
- Hands-on experience with lean manufacturing, Six Sigma, or structured process improvement methodologies
- Proficiency in CAD software such as SolidWorks or AutoCAD for process documentation and tooling design
- Familiarity with FDA or ISO 13485 quality requirements for regulated manufacturing environments
- Ability to develop, validate, and document manufacturing processes to meet production and compliance standards
- Strong data analysis skills using statistical tools to identify process variation and drive continuous improvement
Manufacturing Process Engineer Jobs in Massachusetts: Frequently Asked Questions
How do you become a manufacturing process engineer in Massachusetts?
The standard path is a bachelor's degree in mechanical, industrial, manufacturing, or a closely related engineering discipline from an accredited program. Massachusetts does not require a state-issued license to work as a manufacturing process engineer in industry, though engineers who sign off on public-works projects must hold a Professional Engineer license issued by the Massachusetts Board of Registration of Professional Engineers and Land Surveyors. Most Massachusetts employers in biotech, medical devices, and aerospace also value hands-on co-op or internship experience, which programs at institutions like Northeastern University, UMass Lowell, and Wentworth Institute of Technology are designed to provide.
How much do manufacturing process engineers make in Massachusetts?
Manufacturing process engineers in Massachusetts earn a median of about $109,420 a year, based on May 2025 Bureau of Labor Statistics wage data, ranging from around $81,960 for the lowest 10% to over $161,870 for the top 10%. Pay rises with experience, specialty, and employer.
Which companies hire manufacturing process engineers in Massachusetts?
Employers hiring manufacturing process engineers in Massachusetts right now include Biogen, Draper, and VulcanForms, based on current listings on Migrate Mate as of August 2026. Massachusetts's concentration of FDA-regulated medical device and biotech manufacturers, alongside major aerospace and defense contractors anchored along Route 128 and the Merrimack Valley, means demand from large, established employers remains steady throughout the year.
Which Massachusetts cities have the most manufacturing process engineer jobs?
The cities with the most manufacturing process engineer openings in Massachusetts are Cambridge, Devens, and Orange. Greater Boston dominates because of its dense cluster of biotech, medical device, and defense employers, while cities like Lowell, Andover, and Waltham draw strong demand from the Route 128 and Merrimack Valley technology corridors where major aerospace and electronics manufacturers have long-standing operations.
Are there remote manufacturing process engineer jobs in Massachusetts?
Yes, but they're rare. Manufacturing process engineers typically work on the production floor, with equipment, and alongside cross-functional teams, making fully remote work uncommon by the nature of the role. About 22% of manufacturing process engineer openings tied to Massachusetts are remote or hybrid as of August 2026, and those postings tend to involve process documentation, validation protocol writing, or supplier quality roles where the hands-on requirement is lower.
How can I get hired as a manufacturing process engineer in Massachusetts with little or no experience?
The most realistic entry path is a co-op or internship during your engineering degree, as Massachusetts employers in biotech and defense routinely convert strong co-op performers into full-time hires. Northeastern University's cooperative education program and UMass Lowell's engineering co-op track place students directly with manufacturers across the state. For candidates already holding a degree, applying for process technician, manufacturing associate, or quality engineer roles at medical device companies like Boston Scientific or Hologic provides a route into process engineering without prior title-specific experience. A certification in lean manufacturing or Six Sigma Green Belt gives early-career candidates a measurable edge.
Where can I find and apply to manufacturing process engineer jobs in Massachusetts?
You can find and apply to manufacturing process engineer jobs in Massachusetts on Migrate Mate, which lists current Massachusetts openings from employers actively hiring. Search the available roles, find the ones that match your experience and location, and apply directly to the ones that fit.
See All 19 Manufacturing Process Engineer Jobs in Massachusetts
Find roles in Massachusetts that match your experience and apply in just a few clicks.
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