Process engineer jobs in Manchester, NH - 964 jobs
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Electronics Process Engineer, SMT & Rework
Circuit Technology Center, Inc.
Process engineer job in Haverhill, MA
Circuit Technology Center is a national leader in high reliability circuit board rework, repair, and modification. We support aerospace, defense, medical, and advanced technology customers who rely on us to solve complex board level challenges that require deep technical judgment and hands on expertise.
We are hiring an Electronics ProcessEngineer, SMT & Rework to support our production and engineering teams. This role is ideal for an engineer with hands on electronics manufacturing or SMT experience who wants to deepen their expertise in board level rework, thermal processes, and high reliability electronics.
This is a hands on, shop floor focused role working closely with experienced technicians on complex assemblies.
What You'll Do
Support SMT and rework process setups including thermal profiling, airflow control, and heat management
Assist with hot air and rework system setup for complex assemblies
Evaluate circuit boards for repairability, component sensitivity, and rework risk under guidance
Support troubleshooting of SMT and rework related defects and failures
Help interpret schematics, BOMs, drawings, and technical documentation
Assist with process documentation, work instructions, and continuous improvement efforts
Work directly with technicians to support safe, repeatable, and reliable rework processes
What You Bring
2 to 8 years of experience in electronics manufacturing, SMT, processengineering, or related fields
Hands on exposure to SMT assembly, reflow, or board level processes
Basic understanding of thermodynamics, heat transfer, and component sensitivity
Ability to read and interpret schematics and technical documentation
Comfort working on the shop floor and supporting technicians
Strong curiosity, problem solving mindset, and willingness to learn from senior engineers
Preferred Experience
Experience in aerospace, defense, medical, or other high reliability electronics environments
Exposure to hot air rework systems, reflow ovens, x ray inspection, or failure analysis
Familiarity with IPC standards such as IPC A 610, J STD 001, or IPC 7711 7721
This role offers hands on exposure to complex electronics, close mentorship from senior engineers, and the opportunity to grow into deeper technical ownership over time.
$73k-111k yearly est. 5d ago
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Process Engineer III
Vaxess Technologies
Process engineer job in Woburn, MA
Vaxess is developing a pipeline of next-generation therapeutics on our novel micro-array patch platform. With only five minutes of wear-time on the skin, the Vaxess' patch combines room temperature stability with simplified application to dramatically alter the way that drugs are delivered. Vaxess is committed to enabling products that are not only more effective, but also more accessible to patients around the world.
Responsibilities
Characterize and improve manufacturing process unit operations by designing, executing, and analyzing process development experiments; communicate results via written reports and oral presentations to internal and project teams
Support manufacturing scale-up by assessing novel equipment, work flows, analytical techniques/PAT, and process configurations
Support manufacturing operations by incorporating equipment and process improvements within established processes and equipment trains, and by revising manufacturing batch records, SOPs, and other controlled documents to reflect changes; contribute to implementing and maintaining Vaxess' Quality System.
Supervise and mentor junior engineer(s) and technicians, including a direct report
Collaborate closely with cross-functional teams to support product development and manufacturing activities
Qualifications
BS in Mechanical Engineering, Biomedical Engineering, or a related discipline
5 - 7 years of relevant direct R&D experience within the medical device or biopharmaceutical industries;
experience working on combination products is highly desirable
Demonstrated success using empirical and first-principles models to inform and analyze experiments; experience with statistical methodologies and working with large data sets (e.g. Six Sigma, DoEs, multivariate techniques) is a plus
Excellent time and project management skills and proven ability to meet goals and deadlines
Demonstrated abilities to learn new skills and fields, creatively solve challenging technical problems, think independently, and work collaboratively in diverse multidisciplinary teams
Entrepreneurial spirit and drive to positively impact global human health
At Vaxess, we're bringing together exceptional talent to drive our product development forward. We value collaboration, curiosity, and a dynamic work environment. To apply, please submit your CV/resume to ******************.
$74k-110k yearly est. 1d ago
Process Engineer
Biotalent
Process engineer job in Lexington, MA
Job Title: ProcessEngineer
Duration: February 2026 - December 2028
Commitment: Full-time (40 hours/week) - On-Site with minimal travel
The ProcessEngineer will support a major capital project involving the design and construction of a new Oral Solid Dosage (OSD) manufacturing facility. Responsibilities include equipment procurement, installation, start-up, and commissioning. The engineer will act as an equipment package owner and serve as the primary technical resource for the project, including assisting with validation activities.
Key Responsibilities
Collaborate with project stakeholders, equipment vendors, site engineering, and automation teams.
Develop equipment bid packages (URS, data sheets, specifications).
Manage equipment purchasing activities from procurement through delivery.
Support facility design and construction activities.
Participate in the equipment CQV lifecycle:
Conduct design reviews and risk assessments.
Create and execute commissioning protocols.
Support validation protocol approval and execution.
Maintain required training and contribute to documentation and protocol development.
Travel to vendor locations as needed for project activities.
Required Experience
Extensive experience in an OSD cGMP environment.
Proven project delivery experience with: Isolators, Downflow booths, Material handling systems (powder-related)
Experience with at least one of the following: Granulation systems (wet and dry), Tablet compression systems, Tablet coaters, Packaging lines (primary and secondary)
$74k-110k yearly est. 1d ago
Supplier Quality Engineer
Sanmina 4.6
Process engineer job in Manchester, NH
Sanmina Corporation (Nasdaq: SANM) is a leading integrated manufacturing solutions provider serving the fastest-growing segments of the global Electronics Manufacturing Services (EMS) market. Recognized as a technology leader, Sanmina Corporation provides end-to-end manufacturing solutions, delivering superior quality and support to Original Equipment Manufacturers (OEMs) primarily in the communications networks, defense and aerospace, industrial and semiconductor systems, medical, multimedia, computing and storage, automotive and clean technology sectors. Sanmina Corporation has facilities strategically located in key regions throughout the world.
Supplier Quality Engineer
Ensure compliance with ISO 13485 and AS9100 requirements for suppliers and supplied parts and enhance our Supply Chain quality. This key role within our Quality team will collaborate closely with Incoming Inspection, Quality Engineering, and Manufacturing and will be the main point of contact for addressing and resolving supplier-related issues and providing an input on continuous improvement activities.
Responsibilities:
Communicate failures to suppliers, request SCARs where necessary and document effectiveness of corrective actions.
Interface with Incoming & Final Inspection, discuss results, document disposition and required approvals to ensure timely closure of Nonconformance Reports.
Serve as a key contributor at the weekly MRB meeting.
Assist concerned departments with evaluating cosmetic specifications and other component requirements requesting input and communication with QE/ME as needed.
Work with Supply Chain to attain RMA numbers, ensure dispositions are carried out
Generate and Distribute Scorecards to suppliers
Interface with customers, suppliers, Eng and QEs to evaluate potential raw material issues.
Look for opportunities to drive preventive actions and continuous process improvement with our suppliers.
Assist as needed with customer audits and regulatory audits.
Provide recommendations for improvements and help drive best practices
Required skills and experience:
Bachelor's in Engineering or Technical field or related experience
5+ years of experience in a Quality Assurance role
Working knowledge of supply chain logistics from raw material to finished goods
Comprehensive understanding of quality control principles, practices, and methodologies.
Familiarity with industry-specific quality standards and regulations (e.g., ISO 9001, AS9100, IPC standards).
Proficient in using various inspection tools and measuring equipment (e.g., calipers, micrometers, gauges, microscopes, multi-meters, Oscilloscopes, and other testing devices).
Keen attention to detail and problem-solving abilities.
Ability to interpret technical documents, blueprints, and specifications.
Excellent written and verbal communication skills.
Proficient in Microsoft Office Suite, knowledge of Google Suite is advantageous
Strong organizational and time management skills.
Ability to work effectively both independently and collaboratively in a fast-paced environment.
Experience as an auditor or supplier auditor is a plus
A demonstrable ability to work with cross-functional teams comprised of members within and outside of our organization
Sanmina is an Equal Opportunity Employer
$77k-95k yearly est. 1d ago
Senior Industrial Process Engineer
Radius Recycling
Process engineer job in Everett, MA
& Responsibilities
The Senior ProcessEngineer Technical Services is responsible for driving overall process technology implementation initiatives, continuous improvement / optimization programs, and leading innovation as it relates to Radius shredders, joint products, and other ferrous and non-ferrous operations. Improving yields, product quality and developing new product streams is a key pillar of the technical services department strategy and as such, this role is a key role in ensuring Radius' success in delivering on improved production metrics, throughput, product quality, sustainable low carbon products and reducing environmental footprint.
Essential Functions
Play a key role in implementing the metal recovery technology strategy and other technological improvements across the Radius enterprise.
Project manage the overall execution of technology, continuous improvement and capital projects, ensuring proper resources are identified and assigned, projects are scoped and scheduled, and progress is monitored and managed.
Lead process improvement and technological advancements in recycling with the goals of enhancing product quality, increasing metal recovery (reduce/divert landfill), help in creating new product streams (plastics, tires, and other adjacencies), and growing process efficiencies (throughput, mechanical availability, etc.).
Establish and maintain necessary relationships and contracts with third party service providers, engineering firms, contractors, and consultants to ensure initiatives are appropriately engineered and adequately resourced.
Act as a technical resource to the management teams (shredder, JP, maintenance, etc.) to assist with any technical opportunities that arise during operations.
Leverage existing systems as well as define and establish new improved systems and processes.
Ensure project budgets are effectively and efficiently utilized and met.
Develop and deliver training and support tools for operations to institutionalize new technologies and process improvements.
Assist in the development of fiscal year capital plans for any of the continuous improvement or reliability projects, including but not limited to, major maintenance projects, outages and others.
Provides process training to employees as necessary.
Work closely with Environmental, Health & Safety teams to ensure adherence to all Radius policies and procedures as well as identify opportunities for sustainability improvements and reducing impact on the environment.
Ensuring a safe work environment for all employees, customers and visitors.
Internal Control Responsibilities
Supports Internal Control process which includes understanding, communicating, and complying with defined internal controls as well as suggesting and making modifications to the policies, procedures, and controls to better match the business.
Communicates upward problems in operations, noncompliance with the code of conduct, or other policy violations or illegal actions.
Interpersonal Contacts
The Senior ProcessEngineer - Technical Services will be required to develop and maintain effective working relationships with Technical Services peers, the Operations team including Operations Managers (Shredder, Shear, Balers and Joint Products), Regional Managers, Purchasing Managers, Maintenance Managers at Radius facilities.
The role will also be required to develop and maintain effective relationships with preferred service providers, equipment suppliers and contractors.
Job Conditions
This position will require frequent travel, up to 60% of the time. Visits to yards in each region can be expected to be under all weather conditions. Physical hazards may be present due to the equipment and machinery used throughout the recycling facility and the presence of the scrap itself. This position may require work beyond normally scheduled hours at times to support operations.
Qualifications
Bachelor's degree in an Engineering Field and 5 years of processengineering and project management experience; or equivalent combination of education, job experience and knowledge.
Previous experience in the scrap metals recycling industry or an adjacent heavy industry (e.g., mining, gas & oil, municipal waste recycling, heavy fabrication & processing) is desirable.
Experience leading and implementing continuous improvement / optimization projects.
In addition, a keen drive for safety at work and understanding of environmental permitting processes.
This position requires possession of a valid driver's license and the ability to drive an automobile.
Ideal Competencies
Ability to apply logical principles to solve practical problems and deal with many variables and determine a specific course of action.
Ability to analyze data, to develop effective strategies from such analysis, and to translate these strategies into effective actions at the operational level.
Accountability
Integrity
Customer Focus
Use of functional expertise
Teamwork
Physical Requirements And Work Environment
Able to: travel domestically and internationally, sit, stand, or walk for up to 6-8 hours per day; bend, crouch; climb, balance, push/pull, lift or carry up to 50 pounds. Able to write by hand and keyboard for extended periods of time. Communication is primarily by phone, email and in person, with other departments within the Radius Group. Visual acuity is needed for close detail work, preparing and analyzing data figures, accounting, and computer use.
$70k-96k yearly est. 4d ago
Senior Process Engineer / Lead Process Engineer
LVI Associates 4.2
Process engineer job in Devens, MA
This organization partners with some of the most recognized brands in the life sciences industry to address complex business needs. Its mission is to drive growth and innovation within the scientific community, supporting researchers, organizations, and companies in solving critical healthcare challenges. The team delivers innovative solutions and services that enable informed decision-making, backed by significant investment in people and capabilities.
Growth is fueled by exceptional professionals who thrive in collaborative environments and share a commitment to improving lives. These dedicated experts make an impact every day.
Culture & Values
Empower and support colleagues
Commit to client success at every turn
Demonstrate courage to do the right thing
Foster an inclusive environment where team members feel respected, engaged, and challenged
Continuously acquire new skills and learn from experiences to enhance collective expertise
Lead ProcessEngineer Responsibilities
Provide technical leadership for CIP/SIP processes, ensuring safe, efficient, and cGMP-compliant operations
Lead or support process improvement and scale-up initiatives
Conduct investigations, identify root causes, and implement corrective/preventive actions for manufacturing issues
Develop and optimize process parameters to ensure consistent product quality and yield
Prepare and review process documentation, including batch records, SOPs, validation protocols/reports, and change control documents
Collaborate with cross-functional teams (R&D, Quality, Validation, Maintenance, Production) for technology transfer and process validation
Support equipment qualification and process validation for new or modified equipment/processes
Analyze production data, generate reports, and recommend improvements to enhance performance and efficiency
Ensure compliance with all safety and regulatory requirements in the manufacturing environment
Requirements
Bachelor's degree or equivalent (STEM preferred; Biomedical or Chemical Engineering ideal)
7-10 years of relevant validation experience in pharma/biologics
Minimum 5 years of cleaning validation experience, including:
Hands-on experience with rinse and swab sampling and visual inspections
Development of CIP and SIP cycles for process piping, transfer panels, and bioreactors
Creation of load patterns for autoclaves and parts/glass washers
Experience with Delta V automation for CIP/SIP
Execution of Riboflavin studies
Familiarity with Ellab ValSuite Pro and ValGenesis systems preferred
Ability to work on-site full-time in Devens, MA
Compensation
National (US) Range: $85,000 - $150,000 USD
Actual salary depends on factors such as experience, training, location, and market conditions.
Benefits
High growth potential in a fast-paced, people-focused organization
Competitive pay plus performance-based incentives
Company-paid life, short-term, and long-term disability insurance
Medical, dental, and vision coverage
FSA, DCARE, commuter benefits
Supplemental life, hospital, critical illness, and legal insurance
Health savings account
401(k) retirement plan with employer match
Paid time off (with rollover option) and holidays
Sick time as needed
Tuition reimbursement
Team social activities
Employee recognition and referral programs
Paid parental leave and bereavement
$85k-150k yearly 3d ago
Applications Filtration Engineer
Critical Process Filtration
Process engineer job in Nashua, NH
About the Company
Critical Process Filtration, a TCPA Company, a leading manufacturer of high-quality filtration solutions for pharmaceutical, electronics, process water, and gas filtration is looking for a
Applications Filtration Engineer.
About the Role
The Applications Filtration Engineer will support the development, evaluation, and optimization of filtration technologies across a broad range of bioprocessing and industrial applications. This role plays a key part in shaping next-generation products through experimental research, customer application analysis, and cross-functional collaboration. The Applications Filtration Engineer will be responsible for designing studies, generating performance data, supporting product development, and ensuring our filtration solutions meet both technical and customer-driven requirements. This role offers the opportunity to contribute directly to innovative filtration solutions that serve high-growth global markets.
Responsibilities
Technology & Application Development
Support the development and characterization of filtration technologies including normal flow filtration, tangential flow filtration, and solid/liquid separation systems.
Design and execute laboratory experiments to assess filter performance, validate test methods, and evaluate new materials and device configurations.
Analyze performance data and use statistical tools to develop insights, optimize designs, and provide recommendations for product improvements.
Translate customer application needs into engineering requirements to guide internal R&D efforts.
Customer & Market Support
Partner with sales, marketing, and product management to provide technical expertise for key customer applications.
Assist in field evaluations, prototype testing, and troubleshooting to ensure optimal performance in customer processes.
Support the preparation of technical documentation, application notes, presentations, and training materials.
Cross-Functional Collaboration
Work closely with manufacturing, quality, regulatory, and engineering teams to ensure product readiness and alignment with customer expectations.
Participate in product development reviews and provide data-driven input on design, performance, and application requirements.
Engage with internal stakeholders to drive continuous improvement in test methods, product understanding, and application knowledge.
Innovation & Research
Identify emerging filtration technologies, materials, and methods that can enhance performance or open new market opportunities.
Contribute to intellectual property development, internal reports, and industry conference presentations.
Qualifications
Bachelor's, Master's, or PhD in Chemical Engineering, Biochemical Engineering, Biomedical Engineering, Mechanical Engineering, or another STEM discipline.
Relevant experience in biotechnology, bioprocessing, filtration, or related laboratory research.
Strong understanding of filtration principles, membrane technologies, or downstream bioprocessing.
Experience designing and conducting laboratory experiments and developing test methods.
Proficiency with statistical analysis, DOE, and data processing tools (e.g., Minitab, Excel, Python, MATLAB).
Familiarity with data acquisition systems, sensors, and laboratory instrumentation.
Knowledge of computational modeling or fluid dynamics (e.g., COMSOL) is a plus.
Effective communication skills with the ability to present technical information to multiple audiences.
Demonstrated problem-solving ability and a track record of technical accomplishments.
Equal Opportunity Statement
Critical Process Filtration is proud to be an equal opportunity employer.
EEO Statement: We do not discriminate in hiring on the basis of sex, gender identity, sexual orientation, race, color, religious creed, national origin, physical or mental disability, protected Veteran status, or any other characteristic protected by federal, state/province, or local law.
$81k-109k yearly est. 3d ago
Device Engineer (PhD)
Analog Devices 4.6
Process engineer job in Wilmington, MA
Come join Analog Devices (ADI) - a place where Innovation meets Impact. For more than 55 years, Analog Devices has been inventing new breakthrough technologies that transform lives. At ADI you will work alongside the brightest minds to collaborate on solving complex problems that matter from autonomous vehicles, drones and factories to augmented reality and remote healthcare.
ADI fosters a culture that focuses on employees through beneficial programs, aligned goals, continuous learning opportunities, and practices that create a more sustainable future.
About Analog Devices
Analog Devices, Inc. (NASDAQ: ADI ) is a global semiconductor leader that bridges the physical and digital worlds to enable breakthroughs at the Intelligent Edge. ADI combines analog, digital, and software technologies into solutions that help drive advancements in digitized factories, mobility, and digital healthcare, combat climate change, and reliably connect humans and the world. With revenue of more than $9 billion in FY24 and approximately 24,000 people globally, ADI ensures today's innovators stay Ahead of What's Possibleā¢. Learn more at ************** and on LinkedIn and Twitter (X).
Job Description
The candidate will be part of a multifunctional group that defines, develops and delivers innovative device and process solutions to enable and enhance technology platforms needed for ADI's long term scale and success in power products. The person should have a deep understanding of semiconductor devices and silicon processing technology.
Responsibilities and Duties include but not limited to:
Design semiconductor devices and define process DOE splits in the fab
Setup test measurements in lab and collect automated data as needed
Define optimum process and device layouts
Support technology qualification and implementation for new products
Support production ramp up of new technologies and products
Minimum Qualifications:
Advanced degree in electrical engineering, material science or similar discipline
Expertise in lab measurement and data analysis tools
Strong analytical mind, problem solving skills, good communicator and team player
For positions requiring access to technical data, Analog Devices, Inc. may have to obtain export licensing approval from the U.S. Department of Commerce - Bureau of Industry and Security and/or the U.S. Department of State - Directorate of Defense Trade Controls. As such, applicants for this position - except US Citizens, US Permanent Residents, and protected individuals as defined by 8 U.S.C. 1324b(a)(3) - may have to go through an export licensing review process.
Analog Devices is an equal opportunity employer. We foster a culture where everyone has an opportunity to succeed regardless of their race, color, religion, age, ancestry, national origin, social or ethnic origin, sex, sexual orientation, gender, gender identity, gender expression, marital status, pregnancy, parental status, disability, medical condition, genetic information, military or veteran status, union membership, and political affiliation, or any other legally protected group.
EEO is the Law: Notice of Applicant Rights Under the Law.
Job Req Type: Graduate JobRequired Travel: Yes, 10% of the time The expected wage range for a new hire into this position is $108,800 to $149,600.
Actual wage offered may vary depending on work location, experience, education, training, external market data, internal pay equity, or other bona fide factors.
This position qualifies for a discretionary performance-based bonus which is based on personal and company factors.
This position includes medical, vision and dental coverage, 401k, paid vacation, holidays, and sick time, and other benefits.
$108.8k-149.6k yearly Auto-Apply 60d+ ago
Semiconductor Process Engineering Intern
MacOm 4.5
Process engineer job in Lowell, MA
MACOM designs and manufactures semiconductor products for Data Center, Telecommunication, and Industrial and Defense applications. Headquartered in Lowell, Massachusetts, MACOM has design centers and sales offices throughout North America, Europe, and Asia. MACOM is certified to the ISO9001 international quality standard and ISO14001 environmental management standard.
MACOM has more than 75 years of application expertise with multiple design centers, Si, GaAs and InP fabrication, manufacturing, assembly and test, and operational facilities throughout North America, Europe, and Asia. Click here to view our facilities. In addition, MACOM offers foundry services that represents a key core competency within our business.
MACOM sells and distributes products globally via a sales channel comprised of a direct field sales force, authorized sales representatives, and leading industry distributors. Our sales team is trained across all of our products to give our customers insights into our entire portfolio.
Semiconductor ProcessEngineering Intern
Role Overview:
As a member of the RF Technology Development team, the Semiconductor ProcessEngineering Intern will work alongside experienced engineers to develop key process modules and designs supporting new technology releases.
During the 12 weeks each Intern will:
* Be given an individual and well-defined project with set outcome goals.
* Gain hands on experience.
* Receive excellent training and ongoing supervision.
* Be invited to attend an intern webinar series.
* Attend networking/social events.
* Attend and present at Poster Session about each Interns project successes and pitfalls.
* Receive formal, written feedback.
Requirements:
* Student enrolled in B.S., M.S. or Ph.D. program in Electrical Engineering, Materials Science and Engineering, Chemical Engineering or equivalent.
* Strong data analysis capability, including proficiency with Excel, JMP, Minitab or similar software packages.
* Prior semiconductor fabrication experience highly preferred, including familiarity with conventional process modules (photolithography, plasma processes, physical/chemical vapor deposition, metrology, etc.).
* Familiarity with semiconductor device physics preferred.
* Excellent written and verbal communication skills.
* Demonstrated self-starter capable of working independently.
* Due to ITAR Regulations, U.S. citizenship or permanent residency required.
The hourly Range for this position is $20 - $47 per hour. Actual salary offered to candidates will depend on several factors, including but not limited to, work location, relevant candidates' experience, education, and specific knowledge, skills, and abilities.
EEO:
MACOM is an Equal Opportunity Employer committed to a diverse workforce. MACOM will not discriminate against any worker or job applicant on the basis of race, color, religion, sex, gender identity, sexual orientation, national origin, age, disability, genetic information, veteran status, military service, marital status, or any other category protected under applicable law.
Reasonable Accommodation:
MACOM is committed to working with and providing reasonable accommodations to qualified individuals with physical and mental disabilities. If you have a disability and are in need of a reasonable accommodation with respect to any part of the application process, please call *************** or email HR_*************. Provide your name, phone number and the position title and location in which you are interested, and nature of accommodation needed, and we will get back to you. We also work with current employees who request or need reasonable accommodation in order to perform the essential functions of their jobs.
$20-47 hourly 60d+ ago
Principal Process Engineer, LNP
Crispr Therapeutics 4.6
Process engineer job in Framingham, MA
Since its inception over a decade ago, CRISPR Therapeutics has transformed from a research-stage company advancing programs in the field of gene editing, to a company with a diverse portfolio of product candidates across a broad range of disease areas including hemoglobinopathies, oncology, regenerative medicine, cardiovascular and rare diseases. The Nobel Prize-winning CRISPR science has revolutionized biomedical research and represents a powerful, clinically validated approach with the potential to create a new class of potentially transformative medicines. To accelerate and expand its efforts, CRISPR Therapeutics has established strategic partnerships with leading companies including Vertex Pharmaceuticals. CRISPR Therapeutics AG is headquartered in Zug, Switzerland, with its wholly-owned U.S. subsidiary, CRISPR Therapeutics, Inc., and R&D operations based in Boston, Massachusetts and San Francisco, California.
Position Summary
The Principal ProcessEngineer is responsible for design, construction, commissioning and technical support of process systems at the state-of-the-art cell therapy manufacturing facility being built in Framingham, MA.
The successful candidate will be creative, team oriented and have hands on experience in Engineering support of cGMP manufacturing operations and design of new processes, and a strong grasp process equipment within a multi-product, FDA regulated, cGMP facility. The ideal candidate will participate in all levels of design, startup, and operations including on the floor support of systems and issues. They will serve as a consultant to management on major engineering challenges pertaining to policies, plans, and objectives and will report directly to Head of ProcessEngineering.
Responsibilities
Design, specification, and selection of single use equipment systems
Generate system user requirement specifications (URS)
System SME representative in design reviews
Support automation and monitoring systems integration
Generate facility capacity models and design the development of COGs models
Provide and delegate technical support of Commissioning & Qualification activities (approval of protocols and reports)
Technical guidance SME and deliver analysis for the resolution of equipment related deviations and investigations
Lead implementation of process improvement projects through change control
Co-author department procedures and specifications
Minimum Qualifications
Bachelor of Science Degree in Chemical, Mechanical, or Bio-Engineering with 15+ years of relevant work experience or PhD and 8+ years of experience
Experience with specification and implementation of single use systems (tangential flow filtration systems a plus)
Excellent attention to detail and capable of managing multiple priorities with aggressive timelines
Strong leadership, interpersonal communication skills and ability to work effectively with internal cross functional teams and external partners and vendors
Proficient at applying good engineering practices, industry guidance, and regulatory requirements
Creative problem solver and decision maker
Preferred Qualifications
Experience with Kneat and Blue Mountain CMMS
Due to the nature of their work, our manufacturing and lab-based positions are located fully on-site.
Principal ProcessEngineer, LNP: Base pay range of $168,000 to $180,000+ bonus, equity and benefits
The range provided is CRISPR Therapeutics' reasonable estimate of the base compensation for this role. The actual amount will be based on job-related and non-discriminatory factors such as experience, training, skills, and abilities.
CRISPR Therapeutics, Inc. is committed to equal employment opportunity and non-discrimination for all employees and qualified applicants without regard to a person's race, color, gender, age, religion, national origin, ancestry, disability, veteran status, genetic information, sexual orientation or any characteristic protected under applicable law.
To view our Privacy Statement, please click the following link: ***********************************************
$104k-145k yearly est. Auto-Apply 35d ago
Casting Technology Manufacturing Engineer
GE Aerospace 4.8
Process engineer job in Lynn, MA
The Senior Casting Technology Manufacturing Engineer provides technical leadership for SX or equiax investment castings across the value stream. You will partner with suppliers and cross-functional teams to drive root cause problem solving, improve producibility, increase productivity, and deliver on business objectives. You will own supplier technical relationships, coach on internal processes/specs/methods, qualify new suppliers, and help develop and industrialize alternate casting technologies.
**Job Description**
**Roles and Responsibilities**
+ Provide process and product technical leadership for the Castings commodity, including SX or equiax investment castings.
+ Develop strong working relationships with casting supplier technical teams.
+ Partner with suppliers to identify and implement corrective actions to eliminate the cause and prevent recurrence.
+ Act as a change agent to advance world-class performance and standard work across the supply base.
+ Own supplier technical relationships; mentor suppliers on GE Aerospace processes, specifications, and methods; ensure compliance and capability.
+ Lead cross-functional problem solving, to identify true root cause and implement sustainable corrective and preventive actions.
+ Improve manufacturability through design-for-casting, specification clarity, and process capability improvements.
+ Clearly communicate progress, risks, challenges, and countermeasures to leadership and stakeholders.
+ Review and approve significant/special processes; ensure adherence to standards and qualification requirements.
+ Collaborate with Quality and Design Engineering to ensure new and changed processes meet established metrics; align with other commodities on strategy and objectives
+ Partner with suppliers and internal teams to interpret drawings/specifications, ensuring conformance and clarity.
+ Identify and onboard new suppliers; lead technical qualifications and readiness through Manufacturing and Quality Planning reviews and support supplier Castings Audits.
+ Ability to travel to supplier sites 30%-50%
**Minimum Required Qualifications**
+ Bachelor's degree in Engineering (Materials/Metallurgy, Mechanical, Manufacturing, or related field)
+ Minimum of 5 years of materials engineering, castings, mechanical engineering or a related field
**Desired Characteristics and Experience**
+ Additive manufacturing experience.
+ Metal Injection Molding (MIM) experience.
+ Proficiency with Siemens NX or comparable CAD.
+ Sand Castings Experience.
+ Titanium Experience.
+ Significant experience in investment castings (SX or equiax), with demonstrated yield, capability, and cost improvements
+ Hands-on expertise across investment casting special processes (wax, shell, melt/solidification control, heat treat, HIP, NDT) and specification compliance.
+ Strong problem solving and project management skills.
+ New Product Introduction experience.
+ Experience maturing technologies and processes.
+ Excellent communication and stakeholder management; ability to influence without authority
+ Humble learner: Respectful, receptive to feedback, agile, and continuously improving; seeks out diverse perspectives.
+ Transparent communicator: Shares critical information proactively; speaks with candor; engages constructively to resolve issues.
+ Focused and accountable: Fast learner with strong ownership; meets commitments and drives results against SQDC targets ( _Safety, Quality, Delivery and Cost in that order)_ .
**Pay and Benefits:**
+ The salary range for this position is $ 116,000.00 - 155,000.00. The specific salary offered to a candidate may be influenced by a variety of factors including the candidate's experience, their education, and the work location. In addition, this position is eligible for a performance bonus/variable incentive plan.
+ GE provides a comprehensive benefits package that provides access to plans which support the overall wellbeing of our employees and their dependents. These benefits include, but are not limited to, health care coverage (medical, dental, vision, pharmacy), a retirement plan that includes Company Retirement Savings and a 401K with Company matching, Life Insurance options, Disability coverage, paid time-off, EAP, and more.
Healthcare benefits include medical, dental, vision, and prescription drug coverage; access to a Health Coach, a 24/7 nurse-based resource; and access to the Employee Assistance Program, providing 24/7 confidential assessment, counseling and referral services. Retirement benefits include the GE Retirement Savings Plan, a tax-advantaged 401(k) savings opportunity with company matching contributions and company retirement contributions, as well as access to Fidelity resources and planning consultants. Other benefits include tuition assistance, adoption assistance, paid parental leave, disability insurance, life insurance, and paid time-off for vacation or illness.
General Electric Company, Ropcor, Inc., their successors, and in some cases their affiliates, each sponsor certain employee benefit plans or programs (i.e., is a "Sponsor"). Each Sponsor reserves the right to terminate, amend, suspend, replace, or modify its benefit plans and programs at any time and for any reason, in its sole discretion. No individual has a vested right to any benefit under a Sponsor's welfare benefit plan or program. This document does not create a contract of employment with any individual.
GE Aerospace offers comprehensive benefits and programs to support your health and, along with programs like HealthAhead, your physical, emotional, financial and social wellbeing. Healthcare benefits include medical, dental, vision, and prescription drug coverage; access to a Health Coach from GE Aerospace; and the Employee Assistance Program, which provides 24/7 confidential assessment, counseling and referral services. Retirement benefits include the GE Aerospace Retirement Savings Plan, a 401(k) savings plan with company matching contributions and company retirement contributions, as well as access to Fidelity resources and planning consultants. Other benefits include tuition assistance, adoption assistance, paid parental leave, disability insurance, life insurance, and paid time-off for vacation or illness.
GE Aerospace (General Electric Company or the Company) and its affiliates each sponsor certain employee benefit plans or programs (i.e., is a "Sponsor"). Each Sponsor reserves the right to terminate, amend, suspend, replace or modify its benefit plans and programs at any time and for any reason, in its sole discretion. No individual has a vested right to any benefit under a Sponsor's welfare benefit plan or program. This document does not create a contract of employment with any individual.
_This role requires access to U.S. export-controlled information. Therefore, employment will be contingent upon the ability to prove that you meet the status of a U.S. Person as one of the following: U.S. lawful permanent resident, U.S. Citizen, have been granted asylee or refugee status (i.e., a protected individual under the Immigration and Naturalization Act, 8 U.S.C. 1324b(a)(3))._
**Additional Information**
GE Aerospace offers a great work environment, professional development, challenging careers, and competitive compensation. GE Aerospace is an Equal Opportunity Employer (****************************************************************************************** . Employment decisions are made without regard to race, color, religion, national or ethnic origin, sex, sexual orientation, gender identity or expression, age, disability, protected veteran status or other characteristics protected by law.
GE Aerospace will only employ those who are legally authorized to work in the United States for this opening. Any offer of employment is conditioned upon the successful completion of a drug screen (as applicable).
**Relocation Assistance Provided:** No
\#LI-Remote - This is a remote position
GE Aerospace is an Equal Opportunity Employer. Employment decisions are made without regard to race, color, religion, national or ethnic origin, sex, sexual orientation, gender identity or expression, age, disability, protected veteran status or other characteristics protected by law.
$116k-155k yearly 30d ago
Process Development Associate
Integrated Resources 4.5
Process engineer job in Lexington, MA
A Few Words About Us Integrated Resources, Inc is a premier staffing firm recognized as one of the tri-states most well-respected professional specialty firms. IRI has built its reputation on excellent service and integrity since its inception in 1996. Our mission centers on delivering only the best quality talent, the first time and every time. We provide quality resources in four specialty areas: Information Technology (IT), Clinical Research, Rehabilitation Therapy and Nursing.
With todays growing demand for talented and well qualified professionals, its more important than ever to partner with a company that employs innovative measures to meet your demands. Our expert team of highly trained counselors work hand in hand with every client forming a partnership of understanding and commitment. Our clients know that they can rely on us for prompt response times and reliable staff to meet their workforce demands. Our employees know that they can trust our support for their career development and personal growth.
IRI is proud to be JCAHO Certified by the Joint Commissions of Health, MBE Certified by the State of NJ and the National Minority Supplier Diversity Council (NMSDC) and SBE Certified by the State of NJ.
We have been honored by the following:
Top 100 Diversity Owned Business in NJ for 2007, 2008 and 2009
Top 500 Privately-Held Business in the US
Top 500 Diversity Owned Business in the US
Top 100 Subcontinent Asian American Business in the US
We have also been listed to the Inc. 5000 List of fastest-growing, privately-held companies in the US in 2007, 2008, 2009 and 2010 and honored as an Emerging Business of the Year finalist by NJ BIZ in 2009.
Job Description
Location- Lexington, MA Duration- 9m +++ Development Engineer / Associate (Contract) - Clinical Drug Product Manufacturing Sciences (CDPMS) The Development Engineer / Associate - CDPMS will assist drug product tech transfer teams with project management support. Project management support will include scheduling, resource planning, and project task tracking. A candidate with the right experience would have the opportunity to lead a drug product tech transfer team. The primary responsibility of the candidate will be to perform project management activities to manage the external manufacture of clinical trial materials. In addition, the candidate will coordinate external research projects such as compatibility and filter validation studies. Additional responsibilities will include performing drug product process development studies in collaboration with drug product manufacturing and formulation development teams. The Development Engineer / Associate will also analyze experimental data, document results and conclusions in technical reports, and assist Senior Staff with drug product tech transfer management projects. This will be a visible and hands on role with opportunities to contribute to multiple clinical stage programs. In this role, the Development Engineer / Associate must be able to work independently and be self-motivated. The candidate must manage time efficiently to balance multiple projects and priorities. Excellent organization and communication (oral and written) skills are required.
Qualifications
Qualifications ⢠BS/MS in degree in chemical, biochemical, biomedical engineering, chemistry or related field ⢠3-6 years industry experience in formulation and/or drug product process development ⢠Experience in supporting tech transfer projects to contract research and/or manufacturing organizations ⢠Project management experience including time and resource scheduling ⢠Experience in a GMP environment or GLP laboratory is preferred ⢠Experience with Microsoft Project, Vizio, and advanced Excel spreadsheets is preferred ⢠Experience managing outsourced research projects is a plus ⢠Knowledge of statistical design of experiments is a plus
Additional Information
All your information will be kept confidential according to EEO guidelines.
$57k-69k yearly est. 60d+ ago
Engineer, Combination Device MS&T (JP13077c)
3 Key Consulting
Process engineer job in Cambridge, MA
Business Unit: Physical Methods Development Modelling and Emerging Methods Employment Type: Contract Duration: 2+ years with likely extensions and/or conversion to hire.
Rate: $38 - $42/hour W2
Posting Date: 7/24/2024.
Notes: Only qualified candidates need apply. Can be within commutable distance of client's Cambridge, MA. facility.
3 Key Consulting is hiring! We are recruiting an Engineer, Combination Device MS&T for a consulting engagement with our direct client, a leading global biotechnology company.
Job Description:
Our ideal candidate will have:
3 YOE in field desired with bachelors.
Experience working in a regulated industry, exposure to GMPs, Medical Device experience is highly desired.
Mathematical background fundamentals of statistics.
Useful to have exposure to test method development, CAD design, SolidWorks, mechanical modeling.
Nice to have programming R and python experience. hands on technical experience useful, comfortable working within a lab.
Position involves support of senior staff in the initiation, design, and delivery of projects, particularly for the Combination Product Operations MS&T - Physical Sciences and Engineering (PSE) organization. Responsibilities include development and lifecycle management of Physical GMP Test Methods, lifecycle management of integrated testing machines, development and validation of test methods. The successful candidate employs basic engineering skills and practices to gather user requirements and translate them into technical documentation. Assist with project definition by performing engineering studies and assessment for automated test systems installations. Perform field evaluations of existing systems and provide engineering design recommendations.
The ideal candidate enjoys tackling challenges and excels at organizing information from numerous sources to provide well-constructed deliverables. This individual has a passion for modeling, analytics, and technology. The successful candidate will be given opportunities to apply their expertise to enhance the way data is used to inform and make decisions
This may include, but is not limited to, the following:
Collaborate with Engineers using the system to edit, develop, and run automated, experimental protocols.
Knowledge on Equipment and Method validation principles, generation of Lifecycle Documentation such as FAT/SAT, IQ/OQ, equipment characterization protocols, Gauge Repeatability and Reproducibility studies
Assisting Engineers to successfully develop, transfer and execute processes on the integrated platforms and equipment.
Developing, enhancing, automating, and managing test data
Network with manufacturing and quality organizations internal to client.
Ensuring all tasks and responsibilities are performed according to industry-leading scientific standards & accurately documented per SOPs
Monitoring technological developments in the field & evaluation of new technologies
Top Must Have Skill Sets:
Excellent verbal and written communication skills to communicate project status and risks associated with integrated timelines to leadership
Mathematical background fundamentals of statistics
Ability to manage multiple, competing priorities simultaneously
Day to Day Responsibilities:
Collaborate with Engineers using the system to edit, develop, and run automated, experimental protocols.
Run Gauge Repeatability and Reproducibility studies
Assisting Engineers to successfully develop, transfer and execute processes on the integrated platforms and equipment.
Basic Qualifications:
Master degree OR Bachelor degree and 2 years of experience OR Associate degree and 6 years of experience OR High school diploma / GED and 8 years of experience
Preferred Skills:
Experience working in a regulated industry, exposure to GMPs
Excellent verbal and written communication skills to communicate project status and risks associated with integrated timelines to leadership
Statistical analysis, and knowledge of Gage R&R,
Knowledge of Optical measurement devices, force testers, BLE testing
Test method development, CAD design, Solidworks, mechanical modeling
Manufacturing experience, IQ, OQ, and PQ
Preferred Traits:
Passion for proactively identifying opportunities through creative data analysis and modeling
Intellectual curiosity with ability to learn new concepts/frameworks, algorithms, and technology rapidly as needs arise
Ability to manage multiple, competing priorities simultaneously, experience with MS Project
Why is the Position Open?
Supplement additional workload on team
Interview Process:
Phone screen.
Panel Interview.
We invite qualified candidates to send your resume to **************************. If you decide that you're not interested in pursuing this particular position, please feel free to take a look at the other positions on our website ******************************* You are also welcome to share this opportunity with anyone you think might be interested in applying for this role.
Regards, 3KC Talent Acquisition Team
$38-42 hourly Easy Apply 60d+ ago
Process Automation Intern
The Charles Stark Draper Laboratory
Process engineer job in Cambridge, MA
Draper is an independent, nonprofit research and development company headquartered in Cambridge, MA. The 2,000+ employees of Draper tackle important national challenges with a promise of delivering successful and usable solutions. From military defense and space exploration to biomedical engineering, lives often depend on the solutions we provide. Our multidisciplinary teams of engineers and scientists work in a collaborative environment that inspires the cross-fertilization of ideas necessary for true innovation. For more information about Draper, visit ***************
Summary:
Join our team at the Draper Microfabrication Facility in Cambridge, MA as a Summer Intern focusing on process automation! In this role, you will be working to support teams responsible for the development, execution, control, and continuous improvement of metrology and test processes critical to the production of novel, advanced MEMS.
:
Duties/Responsibilities
Design, develop, and enhancement engineering solutions for challenging problems.
Implement, test, perform analysis, and provide documentation support.
Generate and present test reports including plots, tables, evaluation criteria, and conclusions from data collected and analyzed throughout the test process.
Complete assignments designed to develop a practical knowledge of processes, procedures, equipment, facilities, and systems as well as their interrelationships within engineering disciplines.
Performs other duties as assigned.
Program Requirements
Enrolled in an accredited full-time undergraduate or graduate degree program required.
There is flexibility regarding hours and program duration based on applicant's school schedule and availability.
Skills/Abilities
Excellent written and oral communication skills.
Excellent work ethic with the ability to work independently or in a team environment.
Ability to adapt to ever-changing environments, risks, and vulnerabilities.
Strong computer skills including MS Word, PowerPoint and Excel.
Additional Job Description:
What We Need:
Experience scripting with Python and Matlab.
A learning, problem-solving mindset.
Excellence with team-based communication and coordination.
Highly Desired:
Familiarity with MEMS and/or micro/nanofabrication.
Experience with hardware control or automation.
Connect With Draper for Future Opportunities! If you don't find the right posting in our Career Opportunities, you may submit your resume for future consideration.
Job Location - City:
Cambridge
Job Location - State:
Massachusetts
Job Location - Postal Code:
02139-3563
The US base salary range for this full-time position is
$15.00 - $225.00
Our salary ranges are determined by role, level, and location. The range displayed on each job posting reflects the minimum and maximum target salaries for the position across all US locations.
Within the range, individual pay is determined by work location and additional factors, including job-related skills, experience, and relevant education or training. Union ranges will be in compliance with the collective bargaining agreement's approved rates by location and role. Your recruiter can share more about the specific salary range for your preferred location during the hiring process. Please note that the compensation details listed in US role postings reflect the base salary only, and does not include bonuses or benefits.
Our work is very important to us, but so is our life outside of work. Draper supports many programs to improve work-life balance including workplace flexibility, employee clubs ranging from photography to yoga, health and finance workshops, off site social events and discounts to local museums and cultural activities. If this specific job opportunity and the chance to work at a nationally renowned R&D innovation company appeals to you, apply now ***********************
Draper is committed to creating an inclusive environment. We understand the value of inclusivity and its impact on a high-performance culture. All qualified applicants will receive consideration for employment without regard to race, color, religion, sex, disability, age, sexual orientation, national origin, veteran status, or genetic information. Draper is committed to providing access, equal opportunity, and reasonable accommodation for individuals with disabilities in employment, its services, programs, and activities. To request reasonable accommodation, please contact *************.
$37k-52k yearly est. Auto-Apply 4d ago
Co-Op, Materials Process Engineer, Fall 2026 (July - December)
Alloy Enterprises 4.2
Process engineer job in Burlington, MA
Cooling performance limits high-power computing, semi-conductor fab, cell networks, photonics, power electronics, and most of our digital world. Alloy Enterprises enables customers to break through these constraints with novel complex metal components that dramatically improve heat dissipation in high-performance systems. Alloy's patented Stack Forging⢠process enables complex micro-geometries, resulting in single-piece, leak-tight parts that deliver superior cooling performance, lower pressure drops, and exceptional reliability. Founded in 2020, Alloy is a 45-person hardtech startup that has raised over $50M in capital and is shipping components to customers manufacturing servers, lasers, semiconductor equipment, and defense systems.
About The Role
We are looking for a Material ProcessEngineering co-op to help to develop and standardize processes for a novel feedstock material. Strong communication, flexibility, and the desire to āwear many hats'' will all be essential skills for any successful applicant. You will be expected to teach yourself new skills and apply them to complete your tasks and projects, but you will receive guidance and mentorship along the way.
Responsibilities:
Tune process parameters to make performance improvements
Assist in quality control and process improvement efforts for production scale-up
Develop and perform surface characterization testing and metallographic inspection
Perform electron and optical microscopy analysis
Support feedstock alloy development and validation
Develop and perform mechanical testing methods
Design and carry out Design of Experiments and other statistical analysis
Use Alloy's hardware and software to build sample parts and test specimens
Provide feedback to mechanical and software engineers on machine performance
Develop automated data collection, statistical analysis, and reporting on quality metrics
Requirements:
You take ownership of your projects, completing tasks efficiently and effectively
You are adaptable and excel when working in a fast-paced environment
Background or coursework in materials science, mechanical engineering, or controls preferred
Past industry co-ops or internships strongly desired
Pursuing a degree in Mechanical Engineering, Manufacturing, Materials, or Chemistry
Strong communication skills and ability to document technical
Basic SW experience is a plus: Python, linux, excel, Jira, git, or PLC programming
*Pay Range: $23-28/hr dependent on experience and qualifications
Additional requirements
This position will require access to information subject to control under U.S. export control laws and regulations, including the Export Administration Regulations (āEARā) and International Traffic in Arms Regulations (āITARā). Please note that any offer for employment will be conditioned on authorization to receive controlled items without sponsorship for an export license.
Regarding Sponsorship
Applicants must be authorized to work for any employer in the U.S. We are unable to sponsor or take over sponsorship of an employment Visa, including H-1B, H-1C, H-2A, H-2B, H-3, F-1 or OPT at this time.
Equal employment opportunity
We are committed to creating an equitable and inclusive environment for all our employees and seek to build a team that reflects the diversity of the people we hope to serve with our products. We are proud to be an equal opportunity employer.
$23-28 hourly Auto-Apply 14d ago
Aerospace & Defense Quality Engineer
Biotalent
Process engineer job in Newburyport, MA
Aerospace & Defense Quality Engineer - 6-Month Contract
The Quality Engineer will be responsible for the development, implementation, maintenance, and continuous improvement of quality assurance processes in a regulated aerospace and defense environment. This role requires a strong data-driven mindset and hands-on quality engineering expertise to ensure compliance with AS9100/ISO standards, customer requirements, and regulatory obligations.
Responsibilities
Identify, analyze, and resolve quality issues using structured problem-solving methodologies
Perform loss reporting and drive continuous improvement initiatives
Design and implement process control, process improvement, testing, and inspection methods
Develop, execute, and analyze quality metrics and reporting to support data-driven decision-making
Perform and review First Article Inspections (FAI) in accordance with AS9102 requirements
Interpret and apply GD&T per ASME Y14.5 to support inspection planning, nonconformance resolution, and root cause analysis
Ensure compliance with AS9100 and applicable ISO standards across manufacturing and inspection processes
Support and participate in internal, customer, and third-party quality audits
Collaborate cross-functionally with engineering, manufacturing, and supply chain teams to ensure quality requirements are met throughout the product lifecycle
Qualifications
Bachelor's degree in Mechanical, Electrical, Manufacturing Engineering, or a related field (or equivalent experience)
4+ years of quality engineering experience in aerospace, defense, or another regulated manufacturing environment
Strong working knowledge of AS9100, ISO 9001, and aerospace quality system requirements
Experience performing and reviewing First Article Inspections (AS9102)
Proficiency in interpreting engineering drawings and GD&T per ASME Y14.5
Strong knowledge of industry quality tools (e.g., SPC, FMEA, root cause analysis, CAPA)
Demonstrated analytical, data-driven approach to problem solving
Strong communication, documentation, and audit-support skills
To learn more or apply, please contact me at ****************************.
BioTalent Ltd is acting as an employment agency in relation to this opportunity.
$79k-104k yearly est. 4d ago
Quality Engineer I/II
Vaxess Technologies
Process engineer job in Woburn, MA
Vaxess is developing a pipeline of next-generation therapeutics on our novel micro-array patch platform. With only five minutes of wear-time on the skin, the Vaxess' patch combines room temperature stability with simplified application to dramatically alter the way that drugs are delivered. Vaxess is committed to enabling products that are not only more effective, but also more accessible to patients around the world.
The Role:
The Quality Engineer I / II will support Quality Assurance activities for Vaxess' combination product programs, with a strong focus on medical device design controls, risk management, and cGMP compliance. This role provides hands-on quality support across design and development, supplier oversight, process validation readiness, and batch record/data review, aligned with ISO 13485, 21 CFR 820, and applicable combination product regulations (21 CFR 4).
Reporting to the Quality Assurance Manager, this role works cross-functionally with Manufacturing, Process Development, Quality Control, and Material Management to support compliant execution and ensure product quality and safety during early clinical development.
Responsibilities:
Support quality oversight of Vaxess combination product(s) to ensure compliance with safety, efficacy, and regulatory requirements.
Administer and support the Quality Management System (QMS) in accordance with ISO 13485, 21 CFR 820, 21 CFR Part 4 (Combination Products), and applicable FDA and international regulations.
Provide quality support for Design Control activities, including Design History File (DHF) maintenance, design reviews, Design Verification and Validation (DVV), and design changes.
Support risk management activities, including development and maintenance of risk analyses (e.g., FMEA, hazard analyses) and linkage to design and process controls.
Support process validation and qualification activities, including test method validation (TMV), process validation (PV), and equipment qualification, as applicable to Phase I and GMP-ready manufacturing.
Participate in Material Review Board (MRB) activities, including nonconformance assessment, disposition, and documentation.
Perform quality review and approval of batch records, executed manufacturing records, analytical data collection forms, test records, and technical or experimental reports.
Collaborate in supplier quality management activities, including supplier qualification, auditing, monitoring, change evaluation, and periodic requalification.
Author, review, and revise quality documentation, including SOPs, work instructions, test methods, protocols, reports, forms, and specifications.
Support preparation, review, and organization of quality data and documentation for regulatory submissions and inspections.
Contribute to continuous improvement initiatives within the QMS, including CAPA, deviation investigations, and quality metrics.
Qualifications:
Quality Engineer I: Minimum of 3 years of experience in Quality Assurance or Quality Engineering within a cGMP-regulated medical device or combination product environment.
Quality Engineer II: Typically 4-5 years of progressive quality experience in medical devices, pharmaceuticals, biologics, or combination products.
Working knowledge of ISO 13485 and FDA medical device Quality System Regulations (21 CFR 820); familiarity with combination product requirements strongly preferred.
Experience supporting early-phase (preclinical to Phase I) product development is highly desirable.
Experience with design controls, risk management (FMEA), and validation activities preferred.
Experience reviewing GMP documentation such as batch records, test methods, protocols, and reports.
Strong written and verbal communication skills, with the ability to clearly document technical and quality concepts.
Proficiency with Microsoft Office applications (Word, Excel, PowerPoint).
At Vaxess, we're bringing together exceptional talent to drive our product development forward. We value collaboration, curiosity, and a dynamic work environment. To apply, please submit your CV/resume to
******************
.
$80k-104k yearly est. 3d ago
Semiconductor Device Engineer
Analog Devices 4.6
Process engineer job in Wilmington, MA
Come join Analog Devices (ADI) - a place where Innovation meets Impact. For more than 55 years, Analog Devices has been inventing new breakthrough technologies that transform lives. At ADI you will work alongside the brightest minds to collaborate on solving complex problems that matter from autonomous vehicles, drones and factories to augmented reality and remote healthcare.
ADI fosters a culture that focuses on employees through beneficial programs, aligned goals, continuous learning opportunities, and practices that create a more sustainable future.
About Analog Devices
Analog Devices, Inc. (NASDAQ: ADI ) is a global semiconductor leader that bridges the physical and digital worlds to enable breakthroughs at the Intelligent Edge. ADI combines analog, digital, and software technologies into solutions that help drive advancements in digitized factories, mobility, and digital healthcare, combat climate change, and reliably connect humans and the world. With revenue of more than $9 billion in FY24 and approximately 24,000 people globally, ADI ensures today's innovators stay Ahead of What's Possibleā¢. Learn more at ************** and on LinkedIn and Twitter (X).
Semiconductor Device Engineer
ADI's Advanced Physical Technology (APT) group has an opening for a semiconductor device engineer working on Gallium Nitride (GaN) power technology. APT is driving the roadmap and innovation for wide-band-gap (WBG) technologies which are crucial for the rapidly growing datacenter and energy markets. The engineer will join the team to evaluate the current state-of-art devices and to develop the next-generation technologies for ADI power products. The candidate should have good understanding of semiconductor device physics and also experience in relevant areas (e.g. device testing, TCAD simulation, process development, reliability testing, application board design and testing). Experience in GaN is preferred.
Responsibilities include but not limited to:
Device characterization and test automation if needed, using semiconductor device parameter analyzer (e.g. Keysight B1500) and LCR meter.
Test structure design and device layout using Cadence
TCAD simulation
Data analysis and visualization
Optimize device design, layout and/or process to improve performance, reliability and manufacturability
Work with different teams (e.g. test, reliability) to support technology qualification
Work with design engineers to support implementation in new products
Qualifications:
A Bachelor's Degree in Electrical Engineering, Physics or Material Science is required. A Master's or Ph.D. Degree is preferred.
Experience in lab measurement and data analysis is a must.
Experience in device fabrication, Synopsys TCAD, Cadence layout, application board design and testing is preferred.
Good problem-solving and communication skills, and team player.
For positions requiring access to technical data, Analog Devices, Inc. may have to obtain export licensing approval from the U.S. Department of Commerce - Bureau of Industry and Security and/or the U.S. Department of State - Directorate of Defense Trade Controls. As such, applicants for this position - except US Citizens, US Permanent Residents, and protected individuals as defined by 8 U.S.C. 1324b(a)(3) - may have to go through an export licensing review process.
Analog Devices is an equal opportunity employer. We foster a culture where everyone has an opportunity to succeed regardless of their race, color, religion, age, ancestry, national origin, social or ethnic origin, sex, sexual orientation, gender, gender identity, gender expression, marital status, pregnancy, parental status, disability, medical condition, genetic information, military or veteran status, union membership, and political affiliation, or any other legally protected group.
EEO is the Law: Notice of Applicant Rights Under the Law.
Job Req Type: Graduate JobRequired Travel: Yes, 10% of the time The expected wage range for a new hire into this position is $69,600 to $95,700.
Actual wage offered may vary depending on work location, experience, education, training, external market data, internal pay equity, or other bona fide factors.
This position qualifies for a discretionary performance-based bonus which is based on personal and company factors.
This position includes medical, vision and dental coverage, 401k, paid vacation, holidays, and sick time, and other benefits.
$69.6k-95.7k yearly Auto-Apply 60d+ ago
Device Modeling Engineer
MacOm 4.5
Process engineer job in Lowell, MA
MACOM designs and manufactures semiconductor products for Data Center, Telecommunication and Industrial and Defense applications. Headquartered in Lowell, Massachusetts, MACOM has design centers and sales offices throughout North America, Europe and Asia. MACOM is certified to the ISO9001 international quality standard and ISO14001 environmental management standard.
MACOM has more than 75 years of application expertise with multiple design centers, Si, GaAs and InP fabrication, manufacturing, assembly and test, and operational facilities throughout North America, Europe, and Asia. Click here to view our facilities. In addition, MACOM offers foundry services that represent a key core competency within our business.
MACOM sells and distributes products globally via a sales channel comprised of a direct field sales force, authorized sales representatives and leading industry distributors. Our sales team is trained across all of our products to give our customers insights into our entire portfolio.
Device Modeling Engineer
This opening is for a full-time on-site position at MACOM's Lowell, Massachusetts facility working for the Advanced Semiconductor Development business unit. The role is appropriate for a recent college graduate, ideally with either intern experience or 1-2 years of professional experience.
Roles and Responsibilities:
* Work in a multi-disciplinary team with multiple locations to create and develop design technology for the RF, microwave, and millimeter wave market spaces.
* Develop process design kits and associated technology for the Keysight ADS and Cadence AWR design platforms.
* Create and deploy models for various semiconductor process technologies such as GaN, GaAs, and AlGaAs PIN diode.
* Characterize semiconductor process technologies, analyze data, and collaborate with process integration teams to facilitate technology development and enhancement.
* Develop platforms and tools that enhance new product development experience and speed.
* Create and optimize solutions to utilize artificial intelligence and machine learning in ways that benefit MACOM's design and development teams.
Job Qualifications:
* Bachelor's degree or higher in electrical engineering, physics, computer engineering, or equivalent.
* Software development experience in languages such as Python and C++.
* Experience with RF device characterization measurements.
* Experience with RF/microwave design tools such as Keysight ADS or Cadence AWR.
Other Special Skills:
* Excellent spoken and written English.
* Strong planning and organization skills.
* Strong Analytical skills.
* Effective communication skills.
* Ability to work within a team environment.
* Ability to work on own initiative.
The Salary Range for this position is $69,000 - $113,000. Actual salary offered to candidates will depend on several factors, including but not limited to, work location, relevant candidates' experience, education, and specific knowledge, skills, and abilities.
EEO:
MACOM is an Equal Opportunity Employer committed to a diverse workforce. MACOM will not discriminate against any worker or job applicant on the basis of race, color, religion, sex, gender identity, sexual orientation, national origin, age, disability, genetic information, veteran status, military service, marital status, or any other category protected under applicable law.
Reasonable Accommodation:
MACOM is committed to working with and providing reasonable accommodations to qualified individuals with physical and mental disabilities. If you have a disability and are in need of a reasonable accommodation with respect to any part of the application process, please call *************** or email HR_*************. Provide your name, phone number and the position title and location in which you are interested, and nature of accommodation needed, and we will get back to you. We also work with current employees who request or need reasonable accommodation in order to perform the essential functions of their jobs.
Benefits: This position offers a comprehensive benefits package including but not limited to:
* Health, dental, and vision insurance.
* Employer-sponsored 401(k) plan.
* Paid time off.
* Professional development opportunities.
$69k-113k yearly 1d ago
Engineer - Data Collection, Extraction & Analysis - Medical Devices (JP14034)
3 Key Consulting
Process engineer job in Cambridge, MA
Employment Type: Contract Business Unit: Combination Product Stewardship Duration: 18 months (with likely extensions and/or conversion to permanent)
Posting Date: 05/07/25
Pay Rate: $36 - $41/hour W2 only
Notes: Only qualified candidates need apply.
3 Key Consulting is hiring an Engineer - Data Collection, Extraction & Analysis Medical Devices for a consulting engagement with our direct client, a leading global biopharmaceutical company.
Job Description:
We are seeking an enthusiastic and detail-oriented Engineer to join the Combination Product Operations Digital and Data Strategy team. The ideal candidate will design, implement, and optimize digital workflows, ultimately improving efficiency, reducing operational costs, and enhancing the overall performance of the organization. Additionally, the individual will play a key role in creating and delivering insightful reports to inform decision-making. The Engineer will work within a cross-functional organization to ensure successful and efficient onboarding and adoption of Digital capabilities for various business groups with our client.
Why is the Position Open?
Additional hands for current workload.
Top Must Have Skills:
Prefer experience post-graduation
Technical writing
Experience performing data analysis. (Power BI, Tableau, Spotfire)
Interest in working with large quantities of data to enable general workflows such as data processing, cleaning, and labeling.
Strong communication skills and ability to demonstrate and relay technical concepts to different audiences.
Day to Day Responsibilities:
Data Collection and Extraction:
Retrieve and preprocess data from various sources, such as databases, APIs, and flat files.
Initiating and supporting the digitalization of experimental workflows.
Identify areas for improvement, enhance efficiency, and reduce errors in streamlining data capture to reporting.
Data Visualization:
Create informative data visualizations using tools like PowerBI, Tableau, and Spotfire.
Communicate findings to technical and non-technical stakeholders through charts, graphs, and dashboards.
Collaboration and Reporting:
Collaborate with cross-functional teams to understand their data requirements and provide data-driven solutions.
Generate regular reports and presentations to communicate insights and recommendations.
Perform report validations
Perform system installation qualification and operational qualifications
Create documentation to support digital processes, systems, or stakeholder needs.
Basic Qualifications:
Bachelor's degree in Engineering plus 2 years of engineering or data analysis experience, OR;
Master's degree in Engineering
Experience performing data analysis.
Interest in working with large quantities of data to enable general workflows such as data processing, cleaning, and labeling.
Strong communication skills and ability to demonstrate and relay technical concepts to different audiences.
Ability to manage multiple, competing priorities simultaneously.
Ability to deliver work in a fast-paced, multi-project team-oriented environment.
Ability to work in highly collaborative, cross-functional environments.
Preferred Qualifications:
Experience with data science libraries.
Experience in programming languages, such as Python or R.
Experience with combination products, device regulatory requirements, medical device development and engineering, and process controls.
Provide Digital and Data expertise for the different product teams to ensure consistent data model and FAIR (Findable, Accessible, Interoperable & Reusable) data design across the various capabilities implemented.
Identify improvements required to data and attribute models and drive engagement with internal and external stakeholders (incl. software vendor) to obtain enhancements.
Employee Value Proposition:
This role will enable to develop your data analysis skills, implement processes in a corporate environment and gain experience in a GMP environment.
Red Flags:
Lack of Engineering or Computer Science background
Short previous job durations (Less than 6 months)
Lack of technical writing skills
Interview process:
Phone Screening
Interview panel 1 - Video
Interview panel 2 - In Person
We invite qualified candidates to send your resume to **************************. If you decide that you're not interested in pursuing this particular position, please feel free to take a look at the other positions on our website ******************************* You are also welcome to share this opportunity with anyone you think might be interested in applying for this role.
Regards, 3KC Talent Acquisition Team
How much does a process engineer earn in Manchester, NH?
The average process engineer in Manchester, NH earns between $55,000 and $123,000 annually. This compares to the national average process engineer range of $62,000 to $108,000.
Average process engineer salary in Manchester, NH
$82,000
What are the biggest employers of Process Engineers in Manchester, NH?
The biggest employers of Process Engineers in Manchester, NH are: