Advanced engineer jobs in Lynn, MA

WHO WE ARE As the nation's largest producer of clean, carbon-free energy, Constellation is focused on our purpose: accelerating the transition to a carbon-free future. We have been the leader in clean energy production for more than a decade, and we are cultivating a workplace where our employees can grow, thrive, and contribute. Our culture and employee experience make it clear: We are powered by passion and purpose. Together, we're creating healthier communities and a cleaner planet, and our people are the driving force behind our success. At Constellation, you can build a fulfilling career with opportunities to learn, grow and make an impact. By doing our best work and meeting new challenges, we can accomplish great things and help fight climate change. Join us to lead the clean energy future. TOTAL REWARDS Constellation offers a wide range of benefits and rewards to help our employees thrive professionally and personally. We provide competitive compensation and benefits that support both employees and their families, helping them prepare for the future. In addition to highly competitive salaries, we offer a bonus program, 401(k) with company match, employee stock purchase program comprehensive medical, dental and vision benefits, including a robust wellness program paid time off for vacation, holidays, and sick days and much more. Expected salary range of $144,900 to $161,000, varies based on experience, along with comprehensive benefits package that includes bonus and 401(k). PRIMARY PURPOSE OF POSITION Performs advanced engineering problem solving in support of power plants. Responsible for technical decisions. Possesses superior knowledge in functional discipline and its practical application and has excellent knowledge of applicable industry codes and regulations. Functions with recognized industry-level of expertise in a technical area. PRIMARY DUTIES AND ACCOUNTABILITIES Provides in-depth technical expertise to develop, manage and implement engineering activities related to plant safety, reliability, maintainability, and availability ensuring compliance to customer's needs, regulatory requirements, and corporate policies Accountable for the accuracy, completeness, and timeliness of work ensuring proper configuration management and assuring that standard design criteria, practices and codes are used in preparation of plans and specifications. Provide technical expertise and consultation through direct involvement to identify and resolve equipment and system problems Perform independent research, reviews, studies and analyses in support of technical projects Provides initial or complete task management of engineering issues Recommends equipment, new concepts and techniques to improve performance, simplify construction, reduce costs, correct design or material flaws, or comply with changes in codes or regulations Supports plant design modifications, testing and problem solving Assure all engineering products prepared or overseen are in accordance with applicable safety analyses, industry codes, and all regulatory requirements Develop, implement and coordinate functional supervisory activities including, but not limited to, personnel, budgetary accountabilities and planning goals with respect to engineering personnel MINIMUM QUALIFICATIONS BS Engineering, AND 10+ years professional experience with exceptional performance. Approval of VP Engineering required to obtain this classification PREFERRED QUALIFICATIONS Solid performance rating for the last 2+ years in one of the following: Process Engineering experience in the Natural Gas industry Rotating equipment experience (piping design, pumps, compressors, generators, natural gas processing, cryogenics, etc.) Recognized fleet or industry expert in knowledge/skill area Registered structural or professional engineer Also, one of the following: Site/Corporate leadership (leads HITs, project manages outage or on-line work, lead for issue termination, troubleshooting lead Interdepartmental experience

Process Engineer - Medical Device Manufacturing Location: Franklin, MA | Full-Time About the Role We are seeking a Process Engineer III with strong manufacturing experience to support machining operations in the medical device industry. This role involves development and improvement of machining processes, solving complex manufacturing challenges, and driving process improvements to ensure precision, compliance, and efficiency. You will play a key role in equipment selection, capacity planning, and cost analysis while collaborating across engineering, quality, and production teams. Key Responsibilities Develop machining processes and operation sheets from engineering data for complex medical devices. Implement new or improved manufacturing methods, tools, and equipment designs to optimize performance. Lead cost reduction initiatives and evaluate outside processes for quality and efficiency. Design and implement assembly tooling, jigs, and fixtures. Manage multiple projects, track progress, and report regularly to management. Partner with Quality to analyze data and drive corrective actions. Create and maintain clear, accurate documentation to support production, compliance, and knowledge transfer. Ensure compliance with FDA, ISO 13485, ISO 9001, and GMP standards. Train personnel and provide daily communication across departments to resolve production issues. Qualifications Bachelor's degree in Mechanical or Industrial Engineering. 5+ years of experience in machining, CNC equipment, and medical device assembly. Strong knowledge of GD&T, metrology tools (CMM, profilometer, vision systems), and process monitoring. Familiarity with GMP, ISO, Lean manufacturing; Lean Six Sigma certification a plus. Experience with ERP systems (SAP/Oracle) and MS Office tools (Word, Excel, Project, PowerPoint). Excellent communication skills and ability to manage multiple priorities. Proven ability to generate thorough documentation for processes, tooling, and testing. Why Join Us Contribute to the development of life-changing medical technologies. Work in a collaborative, innovation-driven environment. Competitive compensation, benefits, and career growth opportunities. Who we are: KARL STORZ is an independent, family-owned company headquartered in Germany's renowned MedTech manufacturing region. For 80 years, we've pioneered the most groundbreaking innovations in endoscopic surgery, video imaging, and operating room integration to benefit patients and healthcare providers alike. With more than 9,000 associates worldwide and 2,600 in the US, we pride ourselves on harnessing cutting-edge technology, precise workmanship, and unrivaled customer support to help healthcare facilities succeed. With onsite locations and field opportunities across the country, we attract a diverse and talented staff. It's not just about the tools we create-it's about the lives we change, together. #LI-CW1

The Role: Our teams build and contribute to Fidelity's digital presence. As a Principal Search Engineer on the Search Platform team, you will play a key role in designing, developing, and optimizing our search and content discovery platform, supporting millions of customer requests. You will be responsible for implementing and enhancing hybrid search solutions, and leveraging AI/ML techniques to improve search relevance and user experience. Your role will include building, managing, and automating cloud infrastructure to ensure robust, high-performance search capabilities for both internal associates and customers. You'll collaborate with cross-functional teams to deliver innovative search solutions, contribute ideas for product enhancements, and continually develop your technical skills in a fast-paced, team-oriented environment. The Expertise You Have: Deep expertise in implementing, configuring, and tuning enterprise-grade search solutions using Solr (preferred); experience with OpenSearch is a plus. Comprehensive knowledge of information retrieval principles, including both classic approaches (such as TF-IDF, BM25) and advanced neural search techniques (like vector embeddings and transformer-based models). Proficiency in container technologies, especially Kubernetes (AWS EKS preferred) and Docker. Solid understanding of the software development and delivery lifecycle for large-scale systems. Ability to design and implement automation and infrastructure solutions using languages such as Python, Groovy, Shell, and NodeJS. Experience with build tools and package managers (helm, maven, npm, pip, etc.). Familiarity with observability, monitoring, and logging tools such as Datadog, Splunk, or other OpenTelemetry/APM tools. Experience troubleshooting and resolving complex CI/CD pipelines, release issues, and multi-component system environments. Education / Certifications: Advanced degree in Computer Science or a related field, or equivalent professional experience. The Skills You Bring: Proven ability to lead technical efforts from conception through production deployment. Skill in translating business needs into scalable, effective search solutions. Ability to work collaboratively across organizations and drive successful outcomes. Passion and aptitude for learning new technologies and approaches, especially in the search and AI/ML space. Comfort operating in a polyglot development environment. Excellent verbal and written communication skills The base salary range for this position is $107,000-216,000 USD per year. Placement in the range will vary based on job responsibilities and scope, geographic location, candidate's relevant experience, and other factors. Base salary is only part of the total compensation package. Depending on the position and eligibility requirements, the offer package may also include bonus or other variable compensation. We offer a wide range of benefits to meet your evolving needs and help you live your best life at work and at home. These benefits include comprehensive health care coverage and emotional well-being support, market-leading retirement, generous paid time off and parental leave, charitable giving employee match program, and educational assistance including student loan repayment, tuition reimbursement, and learning resources to develop your career. Note, the application window closes when the position is filled or unposted. Please be advised that Fidelity's business is governed by the provisions of the Securities Exchange Act of 1934, the Investment Advisers Act of 1940, the Investment Company Act of 1940, ERISA, numerous state laws governing securities, investment and retirement-related financial activities and the rules and regulations of numerous self-regulatory organizations, including FINRA, among others. Those laws and regulations may restrict Fidelity from hiring and/or associating with individuals with certain Criminal Histories. Most roles at Fidelity are Hybrid, requiring associates to work onsite every other week (all business days, M-F) in a Fidelity office. This does not apply to Remote or fully Onsite roles. Certifications:Category:Information Technology

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 ******************.

Title: Validation Engineer Duration: 6m+ There are 3 roles open here - 2 beginner level (not entirely green but 1-2 yrs is fine) and 1 intermediate level (4+ yrs) KEY RESPONSIBILITIES: Draft and implement Quality System documentation designed to establish good validation practices within the organization. Author URS, IQ, OQ and PQ protocols and execute them in compliance with GDP guidelines and internal quality standards. Support all stages of qualification of Analytical Instrument and Manufacturing equipment. Support all stages of qualification of automated manufacturing equipment Conduct Analytical Instrumentation Qualifications in accordance with USP and Vertex SOPs. Conduct Automation Assessments to ensure compliance with 21 CFR Part 11. Coordinate with vendor personnel to schedule and execute of test plans, if required. Coordinates with the internal stakeholders to safely and effectively schedule CQV activities, whenever required. Effectively works with cross departmental stakeholders, including but not limited to information services, EH&S, Global Security, design teams, and quality. Author documents related to or support process validation related activities that include but not limited to aseptic process simulations (APS), process performance qualification, material qualifications, etc. Develop cycles for sterilization processes and validate them, if required. Completes assigned training and ensures that they are 100% compliant 100% of the time. Ensure that all Validation activities align with the current SOPs, global standards and cGMP guidelines. Supports right-the-first time culture for all documents distributed across the organization. Ensure the Validation team reputation and partnership is flourished with the cross-functional teams. IDEAL CANDIDATES: Demonstrated ability to safely execute Validation activities in a dynamic fast paced environment. Experience developing and executing Validation protocols in a GMP Manufacturing and Analytical Laboratory areas. Receptive to change - Adapts (quickly) to changing circumstances. Flexibility for off-shift hours, including weekend and night shift work. B.A, B.S. in Engineering or related discipline with 5-8 years of Validation experience or equivalent professional experience. Understanding and application of technical principles, theories, and concepts in the field, GMP, ISO, GAMP, ANSI.

SRE with Sterling OMS Skillset with adaptability to Distributed Systems, developing Automations with AI/GenAI tool etc Operations skillset with enough attitude to scale to a Reliability Engineer. Should be able to handle customer communication and coordination with offshore team. # LI-RJ2 Salary Range - $100,000-$120,000 a year

🚀 Contract Opportunity - Quality Engineer (Edifecs Project) 📍 Remote (U.S.-based only) | 💼 7-Month Contract | 💰 W2 Only We're looking for experienced Quality Engineers to join a remote Edifecs project within the U.S. healthcare domain. This is a 7-month W2 contract opportunity with a leading healthcare technology team. Key Responsibilities Review business requirements and data mappings related to the HealthRules Payor ecosystem. Perform manual testing, create and execute test cases, and document results. Design or contribute to comprehensive testing plans. Conduct SQL-based validation and data analysis. Collaborate with technical and business teams to ensure data accuracy and functional integrity. (Optional) Contribute to testing automation or agentic testing initiatives. Required Skills & Experience Strong background in U.S. Healthcare systems and processes. Hands-on experience with HealthRules Payor and HealthRules Data Warehouse. Proficiency in SQL for validation and data testing. Demonstrated experience creating and executing manual test cases. Excellent attention to detail, documentation, and communication skills. Must be authorized to work in the U.S. (W2 only) and reside within the United States. Nice to Have Familiarity with Edifecs integration and testing frameworks. Exposure to automation or agentic testing tools. 📩 Interested? Apply today to join a dynamic remote team working on a transformative U.S. healthcare project.

Employment Type: Full-Time, On-Site Salary Range: $70,000-$109,000/year A leading life sciences organization is seeking a CQV Engineer / Validation Engineer to support commissioning, qualification, and validation activities for manufacturing equipment, systems, and processes in a GMP-regulated environment. This role requires strong experience authoring and executing protocols in ValGenesis and familiarity with electronic protocol management systems. Key Responsibilities Author, edit, and execute commissioning, qualification, and validation documentation (URS, IQ, OQ, PQ) using ValGenesis Manage deviation investigations and root cause analysis; support CAPA resolution Support change management activities, including impact assessments and regression analysis Execute test scripts and document results; maintain clear, detailed records Collaborate with cross-functional teams to meet project timelines Ensure compliance with GxP and 21 CFR Part 11 requirements Qualifications Bachelor's degree in STEM (Engineering, Life Sciences preferred) 3+ years of industry experience in CQV or validation Strong experience authoring and executing protocols in ValGenesis (required) Experience setting up or implementing ValGenesis instances (preferred) Familiarity with validation lifecycle documentation and electronic protocol systems Strong problem-solving and technical writing skills Ability to work full-time onsite in Devens, MA Salary & Benefits Competitive pay plus performance-based incentives Comprehensive benefits: medical, dental, vision, life insurance, disability coverage 401(k) with employer match Paid time off, holidays, and sick time Tuition reimbursement and professional development opportunities

2025-11-11 Country: United States of America Onsite U.S. Citizen, U.S. Person, or Immigration Status Requirements: U.S. citizenship is required, as only U.S. citizens are authorized to access information under this program/contract. Security Clearance: DoD Clearance: Secret At Raytheon, the foundation of everything we do is rooted in our values and a higher calling - to help our nation and allies defend freedoms and deter aggression. We bring the strength of more than 100 years of experience and renowned engineering expertise to meet the needs of today's mission and stay ahead of tomorrow's threat. Our team solves tough, meaningful problems that create a safer, more secure world. Job Summary: An opportunity exists in the Advanced Microelectronics Solutions (AMS) Department, a part of Raytheon, for a 4th Shift EBeam Process Engineer. AMS develops, designs, and manufactures compound semiconductor devices, millimeter/microwave integrated circuits, focal plane arrays, and modules for defense and commercial applications. The individual in this role will serve as a process engineer within the Electron Beam Lithography Workcenter, which will focus primarily on supporting the production line through the operation and support of electron beam lithography tools. They will also support the ancillary E-Beam lithography processes such as resist coat and develop. The ideal candidate will have experience in all aspects of electron beam lithography. They would also demonstrate the ability to analyze data and clearly communicate results with process and development engineers. Further, they would have experience leading or contributing to process improvement projects. The candidate will support the operational goals of the facility through ensuring sustained uptime and utilization of the electron beam tools. The candidate should have a general understanding of the overall techniques involved in semiconductor wafer fabrication and integration, with some experience of analog device processing. Experience with statistical analysis software such as JMP, Minitab, R, etc. is preferred. This position is 100% onsite and will be based in Andover, MA. What You Will Do: Supporting the production line electron beam lithography write tools. Collaborating with Engineering, Operations, and Quality to troubleshoot efforts with Ebeam processes Working with the E-Beam lead engineer to drive efforts to improve the performance and operational efficiency of the area. Supporting capital qualification efforts. Qualifications You Must Have: Typically, a Bachelor's in Science, Technology, Engineering, or Mathematics (STEM) and 3+ years of prior work experience OR a STEM Master's and experience related to electron beam lithography techniques such as gaussian beam write, resist coat and develop, and thermal evaporation. Experience troubleshooting production process equipment. The ability to obtain and maintain a U.S. government issued security clearance is required. U.S. citizenship is required, as only U.S. citizens are eligible for a security clearance. Qualifications We Prefer: Master's in Science, Technology, Engineering, or Mathematics (STEM). Experience supporting process improvement projects Experience working with SQL databases Experience with statistical analysis software (JMP, Minitab, R, SPSS, MATLAB, etc) Experience with compound semiconductor devices. Experience in statistical process control (SPC) Strong communication skills and the ability to clearly present data and analyses Ability to document and maintain production processes. What We Offer: Our values drive our actions, behaviors, and performance with a vision for a safer, more connected world. At RTX we value: Trust, Respect, Accountability, Collaboration, and Innovation. As part of our commitment to maintaining a secure hiring process, candidates may be asked to attend select steps of the interview process in-person at one of our office locations, regardless of whether the role is designated as on-site, hybrid or remote. The salary range for this role is 66,000 USD - 130,000 USD. The salary range provided is a good faith estimate representative of all experience levels. RTX considers several factors when extending an offer, including but not limited to, the role, function and associated responsibilities, a candidate's work experience, location, education/training, and key skills.Hired applicants may be eligible for benefits, including but not limited to, medical, dental, vision, life insurance, short-term disability, long-term disability, 401(k) match, flexible spending accounts, flexible work schedules, employee assistance program, Employee Scholar Program, parental leave, paid time off, and holidays. Specific benefits are dependent upon the specific business unit as well as whether or not the position is covered by a collective-bargaining agreement.Hired applicants may be eligible for annual short-term and/or long-term incentive compensation programs depending on the level of the position and whether or not it is covered by a collective-bargaining agreement. Payments under these annual programs are not guaranteed and are dependent upon a variety of factors including, but not limited to, individual performance, business unit performance, and/or the company's performance.This role is a U.S.-based role. If the successful candidate resides in a U.S. territory, the appropriate pay structure and benefits will apply.RTX anticipates the application window closing approximately 40 days from the date the notice was posted. However, factors such as candidate flow and business necessity may require RTX to shorten or extend the application window. RTX is an Equal Opportunity Employer. xevrcyc All qualified applicants will receive consideration for employment without regard to race, color, religion, sex, sexual orientation, gender identity, national origin, age, disability or veteran status, or any other applicable state or federal protected class. RTX provides affirmative action in employment for qualified Individuals with a Disability and Protected Veterans in compliance with Section 503 of the Rehabilitation Act and the Vietnam Era Veterans' Readjustment Assistance Act. Privacy Policy and Terms: Click on this link to read the Policy and Terms

Who We Are: At Veranova, we believe people are our most important asset, and we are dedicated to building the most talented and diverse workforce in our industry. Our commitment to uncompromising focus on quality, compliance, safety, and excellence in delivery shapes everything we do. We are not just looking for skills; we are seeking innovative individuals who have a mindset open to learning and growth, and a desire to make a difference. Veranova is a global leader in the development and manufacturing of complex active pharmaceutical ingredients (APIs) for pharma and biotech customers. With deep technical expertise and impressive flexibility, we develop solutions and processes that support and accelerate innovation. Join us on our mission to enable current and next-generation therapeutics to improve and save the lives of patients. Role Overview: This role serves as the site SME for all cleaning validation and verification activities related to intermediate and API manufacturing, including facility surfaces and equipment. You'll work closely with cross-functional teams to ensure regulatory compliance and implement effective cleaning strategies that meet customer expectations. This position is key to maintaining high quality and safety standards across manufacturing operations. Additionally, you'll manage the environmental and purified water monitoring programs to ensure consistent product quality throughout the process. Core Responsibilities: Lead the development, execution, and validation of cleaning procedures for equipment, production lines, and facilities. Write and review cleaning validation protocols and reports in compliance with regulatory requirements, ensuring that all materials are free of any residues or contaminants. Coordinate and conduct sampling (e.g., swab, rinse, and surface) and analytical testing to validate cleaning processes and confirm cleaning effectiveness. Develop and maintain cleaning validation schedules to ensure timely completion of required validations Review cleaning validation data, ensuring it meets established acceptance criteria, and make recommendations for process improvements. Qualifications: Required Minimum 7 years of quality assurance experience with an undergraduate degree in engineering, science or related field Minimum of 3 years of experience in contamination control, cleaning validation, environmental monitoring, and/or purified water systems, preferably in a pharmaceutical or biotech manufacturing environment (API CDMO experience is highly desirable) Proven leadership experience in pharmaceutical, API/intermediate, medical device, biologics or related FDA industry Strong knowledge of cGMP, FDA, EMA, ICH guidelines, and other regulatory standards related to contamination control, cleaning validation, environmental monitoring, and purified water systems Experience with microbiological sampling, environmental monitoring, and testing of purified water systems in a regulated pharmaceutical environment Proficiency with risk assessment tools such as FMEA Previous experience working in cross-functional and project-based environments Experience creating metrics for driving continuous improvement Excellent analytical, written and verbal communication and presentation skills and a mindset that promotes a positive work culture Hands-on experience with cleaning validation, TOC analysis, and bioburden reduction strategies Driven and detail-oriented, with a strong understanding of cGMP regulations and previous experience in cleaning validation Experience driving complex projects with the ability to initiate, prioritize, and successfully complete tasks Proven experience working effectively in team situations and as an individual contributor Demonstrated behaviours that model the Veranova culture to achieve an inclusive environment and exceptional business results The ideal candidate will have hands-on experience with sterile and cleaning validation processes, strong technical writing skills, and the ability to execute validation protocols independently Experience in a fast-paced work environment Preferred Certification in contamination control (e.g., PDA Certification in Contamination Control). Knowledge of risk-based approaches to cleaning validation (e.g., Risk Assessment and ICH Q9) Experience with continuous improvement methodologies such as Lean or Six Sigma desire Familiarity with environmental monitoring equipment and purified water system design and validation Salary Range : $90,000 - $100,000 annual base salary Our Commitment: Health & Wellness: Comprehensive health & wellness benefits. Access to mental health resources and wellness programs. Generous PTO and holiday pay policies. Financial Wellness: Veranova is committed to fair and transparent compensation practices. This includes a competitive base salary, eligibility for performance-based bonuses, and an attractive 401(k) Plan with company match. Salary ranges reflect the scope and expectations of the role, and are based on market data, internal equity, and role-specific factors. Final compensation may vary depending on experience, skills, education, and business needs. Professional Development: Opportunities for continuous learning through LinkedIn Learning, workshops, conferences, and mentorship. Tuition Assistance for Undergraduate and Graduate degree programs. Inclusive Culture: At Veranova, an inclusive culture is integral to our values. We welcome people with diverse experiences and perspectives who share our mission to improve and save lives. Even if you don't meet every qualification, we encourage you to apply. Veterans, first responders, and those transitioning from military to civilian life bring valuable skills that strengthen our team. Additional Information: Applicants for this role must be authorized to work in the United States without further employer sponsorship. Agency and Search Firm Representatives: Veranova does not accept unsolicited resumes from agencies and/or search firms for this job posting. All your information will be kept confidential according to EEO guidelines. Veranova is an Equal Opportunity Employer. It is the policy of Veranova to provide equal employment access and opportunity to all persons regardless of age, race, color, national origin, religion, sex, sexual orientation, gender identity and/or expression, physical or mental disability, genetic information, citizenship, marital status, veteran status, or any other characteristic protected by federal, state, or local law. All applications are carefully considered, and your details will be stored on our secure Application Management System. This is used throughout Veranova for the selection of suitable candidates for our vacancies as they arise. Veranova respects your privacy and is committed to protecting your personal information. For more information about how your personal data is used please view our privacy notice .

WHO WE ARE We are a leading cell and gene therapy contract development and manufacturing organization creating cutting-edge therapies that change people's lives. Join a company where collaborative, dedicated, and talented people are the backbone of our culture. Work both autonomously and in driven teams to make life-changing products utilizing ground-breaking science. THE ROSLINCT WAY Here at RoslinCT, our team contributes to the development of revolutionary treatments. We live every day by our core values: Partner Focus, One Team, Personal Growth, Integrity, Innovation, and Trust and Respect. We put our employees at the forefront by providing a flexible and empowering work environment, an attractive benefits package, and an emphasis on work-life balance. Our people are the key to our success. At RoslinCT we focus on developing our corporate culture, people's development, growth, and the ability to impact patients. ACCELERATING YOUR FUTURE The Process Engineer I/II will develop and execute technology transfer plans for RoslinCT's client processes, including working with key stakeholders in Manufacturing, Quality, Technology, and Operations departments. As a technical subject matter expert, the position will support routine production with troubleshooting, technical assessments of deviations, and product disposition evaluations. The position will play a key role in optimizing manufacturing processes and test methods, continuously improving quality, efficiency, and reliability while supporting products through clinical development to commercialization. HOW YOU WILL MAKE AN IMPACT Partner with colleagues in Operations, Quality Control, and Quality Assurance as well as external clients and suppliers to plan technology transfer, equipment setup and qualification, engineering and training runs, and process validation as applicable. Support production and QC with process or equipment troubleshooting, deviation management, corrections and CAPA, as needed Execute feasibility testing of new or alternative technologies and engage with key stakeholders to ensure technology development alignment with RoslinCT and Client program requirements Collaborate with internal partners to experimentally determine key process and product monitoring and control attributes, analyze results and draft technical reports to communicate conclusions Perform test runs and development studies as needed to support client and RoslinCT initiatives Compile comprehensive data packages, operating procedures, and technical documentation to support technology transfer and process improvement Be proactive in identifying opportunities to add value to processes and cross-functional teams WHAT YOU WILL BRING B.Sc. in Biological or Chemical Engineering (or similar) with 2-10 years of relevant process and/or analytical experience within the Cell and Gene Therapy or Biologics industry Hands-on experience with aseptic manufacturing processes, cell culture, and process analytics Experience with equipment support and troubleshooting Demonstrated independence in experimental design, execution, data analysis, and troubleshooting Preferred Qualifications Advanced degree or additional certifications in science, engineering, or cGMP operations Experience with bioreactor cell culture Experience with cell selection, cell washing, lentiviral transduction, and cryopreservation Experience with Microsoft Excel and statistical programs for data analysis and visualization Excellent technical writing and oral communication skills Driven and works well independently and within cross-functional teams *May serve in an “on call” rotation to respond remotely to urgent issues (~1 week per month) OUR COMMITMENT All RoslinCT employees embrace the principles of our culture and values and are deeply committed to fostering an environment where diversity and inclusion are not only valued but prioritized. We believe a diverse and inclusive community empowers us to act courageously, care deeply, and dream boldly to impact people in big ways. RoslinCT is proud to be an equal opportunity employer, we seek to create a welcoming and diverse environment. All applicants will receive consideration for employment without regard to race, color, religion, gender, gender identity or expression, sexual orientation, national origin, genetics, disability, age, veteran status, or any other applicable legally protected characteristics.

Alexander Technology Group is looking for a Quality Engineer for a client based in the Portsmouth, NH area. This is full-time (perm) On-site in Portsmouth, NH Key Responsibilities: Develop and maintain quality systems for combination products. Ensure compliance with FDA, ISO 13485, cGMP, and other standards. Lead risk assessments, root cause analyses, and corrective actions. Oversee testing, validation, and documentation processes. Collaborate with R&D, manufacturing, and regulatory teams. Conduct training on QA practices and support continuous improvement. Perform inspections and product testing to ensure quality standards. Qualifications: Bachelor's in Engineering, Life Sciences, or related field. Strong knowledge of regulatory requirements and quality tools (e.g., Six Sigma, CAPA, FMEA). Excellent problem-solving and communication skills. Able to work independently in a small team environment. Preferred: Experience with design control, eQMS, and statistical tools. ASQ CQE certification. 3+ years in QA/QE roles with combination products. If interested, please send resume to ************************

WHO WE ARE Nextphase.ai is a Data Management solution provider focused on Data Operations services for enterprise data in the cloud. We are leading the innovation agenda with our clients by delivering a portfolio of services to help them improve data quality and manage data governance for their cloud data. NextPhase.ai data management services are tailored to achieve our client's business outcomes thus enabling our clients to focus on monetizing their data while we handle data operations. Nextphase.ai provides you with a dynamic and fun work environment and encourages you to use creative thinking to solve client challenges. Position Overview: We are seeking a dynamic, analytical thinking individual to join our Quality team, this is a contract position focusing on Quality Systems, CAPA, Complaint handling, Internal Audit, metric reporting and process improvement initiatives. The ideal candidate will possess a strong background in medical devices or IVD, with a proven track record in managing quality-related activities in a fast-paced dynamic environment. QMS experience is essential. Responsibilities: This position is responsible for, but not limited to, the following: Supports the overall QMS processes for the organization. Responsible for activities required to ensure compliance of Quality Management Systems (QMS), specifically regarding CAPA, complaints and internal/external audits. Additional responsibilities include supporting other QMS functions such as NCMRs, Supplier Controls, Management Review, Risk Review, etc. Execution and coordination of activities associated with CAPA program, including administration and record management, providing quality input to investigations, reporting, as well as metrics and trending Support CAPA Owners in quality-related technical principles, including but not limited to Problem Solving tools and techniques (Root Cause Analysis, DOE, FMEA, etc.) Investigate customer complaints, from intake through investigation and closure Manages the Internal Audit program, including scheduling audits, ensuring timely response to findings, as well as metrics and trending Development of Quality Metrics, and coordination of quality data collection and analyses for use in monthly metrics meetings and Management Reviews Provide quality assurance support cross-functionally across the organization Develop, implement, and manage Quality Control/Quality System process improvements. Identify opportunities for improvement within the Quality System to ensure compliance and efficiency. Correct or improve gaps/opportunities in an independent fashion by writing and releasing new or revised Quality System documentation Understand how and when to escalate quality issues to leadership team within the organization, presenting data and information necessary to draw conclusions and take action Provide training and support to employees on quality processes and procedures Support work on quality plans, quality processes Minimum Qualifications: Bachelor's Degree in Engineering, Biomedical Science, or other technical discipline preferred, with 3-6 years of relevant experience in medical device industry, including responsibility for Product Quality and/or Quality Systems A working knowledge of Quality System Standards and regulations, including 21 CFR Part 820, ISO 13485, EU MDR Preferred Qualifications: Ability to multitask, handling multiple projects and changing priorities Experience in the creation and documentation of procedures and processes Must be results-driven and exhibit a sense of urgency Proficiency with Microsoft Office - Word, Excel, PowerPoint and Access experience required Ability to communicate ideas and information clearly, effectively, and frequently (both oral and written) Ability to exercise independent judgment in methods, techniques, and evaluation criteria for obtaining results Ability to act independently to determine methods and procedures Problem-solving skills and the ability to resolve issues as they arise Strong interpersonal skills, with the ability to assimilate with various cross-functional teams Applicants must be authorized to work for ANY employer in the U.S. We are unable to sponsor or take over sponsorship or employment visas currently. NextPhase.ai is an equal opportunity employer, and all qualified applicants will receive consideration for employment without regard to race, color, religion, sex, national origin, disability status, protected veteran status, or any other characteristic protected by law.

Join a fast-paced engineering team building cutting-edge electrophysiology and connected medical technologies. As a Senior DevOps Tools Engineer, you'll design and automate the systems, workflows, and dashboards that accelerate product development and strengthen software quality across a highly regulated medical platform. You'll partner closely with engineering, QA, and technical leadership to streamline development processes, build automation that reduces friction, and enable teams to deliver reliable, compliant software at scale. What we offer you in USA We honor the contract terms you prefer. 20 paid vacation days per year 40 working hours per week Retirement Plan 401(K) Medical, Dental, Vision Insurance Plan for you and your Family 100% On-Site position in Newton What You'll Do Design, build, and maintain internal tools, scripts, and dashboards that support development, testing, and verification. Automate workflows across JIRA, Polarion, TestRail, and other platforms to boost efficiency and traceability. Create dashboards and automated reports that give teams real-time insight into quality, coverage, and development progress. Work with cross-functional stakeholders to gather requirements and deliver tailored tooling solutions. Identify gaps in existing processes and drive continuous improvement in a regulated environment. Support AWS-based development pipelines and help teams develop, validate, and deploy cloud-enabled workflows. Required Qualifications Bachelor's degree with 4+ years of software verification experience, or Master's with 2+ years. Familiarity with medical device development standards (IEC 62304, FDA guidance). Strong automation and scripting skills (Python, C++/C#, or similar). Previous experience with AWS cloud environment Experience integrating and automating tools such as JIRA, Polarion, and TestRail. Strong problem-solving abilities and attention to detail. Solid understanding of documentation best practices. Preferred Qualifications Experience with Git and modern version control workflows. Knowledge of HTML, Flask, Nginx, or related web technologies. Experience working in Agile development environments. Strong communication skills and the ability to collaborate in fast-paced teams. Self-starter with entrepreneurial drive and ownership mentality.

Job Posting Start Date 11-21-2025 Job Posting End Date At JetCool, a Flex company, we're at the forefront of liquid cooling innovation, delivering advanced solutions that empower our partners in AI and high-performance computing. United by a shared purpose, our teams are pushing the limits of what's possible and tackling complex challenges. A career at JetCool offers the opportunity to make a real impact by helping build smarter, more sustainable data centers. Together, we're not just advancing technology - we're redefining cooling standards to create a more sustainable tomorrow. Job Summary JETCOOL Technologies is seeking an experienced Manufacturing Engineer in Littleton, MA to join our growing Operation's team to assist with the introduction of a new class of direct to liquid cooling solutions. This roll will work extensively with engineering, manufacturing, quality and program management to ensure the transfer of new design's into mass production are efficient and cost effective to produce. Strong preference will be given to those with a proven track record of working within a phase gate driven NPI process. JETCOOL Technologies is a fast-moving technology company spun out of MIT and now a member of the Flex family. Our technology provides game-changing cooling solutions for aerospace, electric vehicles, and data centers. Join us to be part of one of today's fastest growing industries, while having a positive impact on society sustainability through innovative technologies. What a Typical Day Looks Like: Working in collaboration with Design Engineering and Process Engineering, contribute to design for manufacturing and design for automation feedback to development teams and process flow optimization in support of mass production. This for in-house manufacturing and across Jetcool's global supply chain Design, build, and deploy smart process assembly fixturing, tooling, and quality test tools internally, domestically and at global suppliers that interact with MES systems Create and release revision controlled work instructions, provide operator training (internally and at selected global manufacturing partners) and ensure released processes are cost effective and safe Analyze process yields on an on-going basis, recommend improvements and apply continuous improvement principles to production Be a creator and contributor to the ECO process The Experience We're Looking to Add to Our Team: 4-year college technical degree, masters preferred 5+ years of relevant industry experience Experience working with electro-mechanical systems consisting of fluids and pumps Experience working with PLM, MES and ERP systems Experience working in an aggressive new product introduction environment utilizing a phase gate approach supported by a global supply base Proficiency in 2D and 3D CAD software. Preference given to those with Solidworks experience Ability to travel to domestic and international suppliers 10%-20% of the time What you'll receive for the great work you provide: Full range of medical, dental, and vision plans Life Insurance Short-term and Long-term Disability Matching 401(k) Contributions Vacation and Paid Sick Time Tuition Reimbursement Pay Range (Applicable to Massachusetts)$84,000.00 USD - $115,500.00 USD AnnualJob CategoryOperations Is Sponsorship Available? No JetCool is an Equal Opportunity Employer and employment selection decisions are based on merit, qualifications, and abilities. We do not discriminate based on: age, race, religion, color, sex, national origin, marital status, sexual orientation, gender identity, veteran status, disability, pregnancy status, or any other status protected by law. We're happy to provide reasonable accommodations to those with a disability for assistance in the application process. Please email accessibility@flex.com and we'll discuss your specific situation and next steps (NOTE: this email does not accept or consider resumes or applications. This is only for disability assistance. To be considered for a position at JetCool, you must complete the application process first).

This role is for a Lead Turbine Airfoils Advanced Quality Engineer within the Product Safety & Quality organization. The Advanced Quality Engineer is an accomplished and forward-thinking Quality Engineer that will serve as the strategic arm of our Turbine Airfoil Quality organization. Reporting directly to the Part Family Advanced Quality Leader, this role is pivotal in driving proactive transformations, lead strategic initiatives that enhance quality processes and outcomes, implement policy enhancements to address systemic issues, and fostering a culture of operational and problem solving excellence. The successful candidate will support across the part family to perform Root Cause and corrective actions, read-across activities, standardization, and implement permanent tactical and systemic corrective actions across the part family. This team will also be pivotal in supporting and equipping the broader Turbine Airfoils Quality team with the skills and methodologies needed to achieve superior execution, redesigning processes to align with organizational objectives and continuous improvement principles to create a culture of team based problem-solving and standardization within the manufacturing shops & suppliers and across the value stream. Travel in this role is likely to be 10-50% depending on part family performance and needs. Travel will be primarily to the Turbine Airfoil sites in Eastern United States **Job Description** **Roles and Responsibilities** + Individual contributor with expertise in Quality and/or Turbine Airfoils, with ability to mentor and influence with indirect leadership skills. + Requires an individual contributor with indirect leadership skills and ability to develop talent. Utilizes in-depth knowledge of Turbine Airfoils design & Quality, and analytical thinking to execute policy/strategy. + Helps to define and leads the implementation of the quality organization, process and tools to support strategy. It implements a culture of Quality in the organization and defines and leads improvement initiatives to achieve business excellence. + Assist directly in developing expertise within Quality and Turbine Airfoils manufacturing team. Pivotal to the cultural and technical transformation of the TAVS quality team. + Grow the reputation of the organization. Creates and Influences policy and ensures delivery within own function, linking with other functions of the organization. + Communicates complex messages and negotiates internally and externally with others. Influences peers to take action and may negotiate with external partners, vendors, or customers. + Has moderate influence on part family Quality + Supports diverse cross-functional teams to find creative solutions to address complex problems that may impact the organization. Has the ability to evaluate quality of information received and questions conflicting data for analysis. Uses multiple internal and external resources outside of own function to help arrive at a decision. **Required Qualifications** + Bachelor's degree from an accredited university or college (or a high school diploma / GED with at least 4 years of experience in Turbine Airfoil Quality). + Additional 3 years experience in Turbine Airfoils Quality, Castings, Manufacturing, and/or Engineering + US Person (Refer to Internal Revenue Code section 7701(a)(31) for the definition ) **Desired Characteristics** + Quality Expertise and/or Turbine Airfoil Mechanical Design Expertise + Focused: quick learner, strategically prioritizes work, accountable + Strong Recognized Leadership ability, strong communicator, decision-maker, collaborative + Established project management skills. + Humble: respectful, receptive, agile, eager to learn + Transparent: shares critical information, speaks with candor, contributes constructively + Problem solver: analytical-minded, challenges existing processes, critical thinker + Strong oral and written communication skills. Strong interpersonal and leadership skills. Demonstrated ability to analyze and resolve problems. Demonstrated ability to lead programs / projects. Ability to document, plan, market, and execute programs. Established project management skills. 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. The base pay range for this position is 88,000.00 - 117,000.00 - 146,000.00 USD Annual. The specific pay offered may be influenced by a variety of factors, including the candidate's experience, education, and skill set. This position is also eligible for an annual discretionary bonus based on a percentage of your base salary/ commission based on the plan. This posting is expected to close on January 12, 2026.. _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:** Yes \#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.

Job Details Experienced Leominster - Leominster, MA Full Time Engineering Manufacturing Engineer- Office Furniture DEPARTMENT: Production Exempt FUNCTION This is an engineering position reporting to the manufacturing engineering manager. With general guidance, provides characterization of process optimization strategies and/or troubleshooting of operational issues in the manufacturing, maintenance or capital projects environment utilizing engineering principles. Develops, organizes, analyzes and presents interpretation of results for operational issues or engineering projects of moderate scope and complexity hands-on position that requires most of time spent on factory floor, working with factory associates and production managers, solving problems, implementing changes and improvements Successful candidates thrive on fast paced, ever-changing, and people intense environment RESPONSIBILITIES Program, operate and troubleshoot CNC woodshop machinery Identify manufacturing cost reductions. Execute LEAN manufacturing techniques and design. Optimize work flow and cell designs for shop throughput. Plan, execute, and manage projects to completion Develop and sustain employees training and development on lean concepts. Department oriented support. Investigate corrective action issues through root cause analysis and implement sustainable solutions REQUIREMENTS/ SKILLS Bachelor's degree preferred, a minimum of 5 years related experience/training, or equivalent combination of education and experience CNC operation and programming experience preferred Strong computer skills, Microsoft office, ACAD or Solidworks, MRP Hands on Team player Self-directed - does not need supervision Communicate clearly and effectively both verbally and in writing. Bi-lingual a plus (Spanish preferred) Strong mechanical aptitude and troubleshooting skills Any past experience with machinery, automation, CAD, welding, assembly preferred Understanding of Lean Manufacturing Concepts is desirable AIS offers a friendly and casual workplace with competitive salary and benefits program. Benefits include medical and dental, 401K, FSA, and a bonus program. We are looking for someone with a good work ethic and enthusiasm for working in a fast-paced environment as we continue our strong growth in the marketplace We are an Equal Opportunity Employer and do not discriminate on the basis of race, color, religion, sex, sexual orientation, age, genetic information, national origin, veteran status, membership in or application to the uniformed services, physical or mental disability or any other classification protected by applicable law. At AIS, we have a strong set of values that guide our business and help us align with our customers. We listen to our Customers. We rely on our Employees. We honor Integrity. We embrace Continuous Learning. We lead with Design. We create Value. We work to make the World better.

At WHOOP, we're on a mission to unlock human performance and healthspan. WHOOP empowers members to perform at a higher level through a deeper understanding of their bodies and daily lives. WHOOP is seeking a Staff Technical Lead in Electrical Engineering to drive continuous improvement efforts across our hardware platform. This individual will lead a team of engineers focused on sustaining and advancing the performance, quality, and cost-efficiency of WHOOP products at scale. You will play a critical role in bridging engineering and manufacturing, ensuring the electrical design evolves to meet the demands of high-volume production while supporting WHOOP's mission of unlocking human potential.RESPONSIBILITIES: Lead a team of 2-3 electrical engineers focused on sustaining PCB's, Batteries, and Antennas throughout the product lifetime with iterative improvements and rigorous validation Identify, scope, and drive design changes that increase electrical performance, improve reliability, reduce cost, or support component second-sourcing Collaborate with manufacturing, quality, and failure analysis teams to identify root causes of field and production issues, and implement robust electrical solutions with detailed validation plans Support yield improvement initiatives across global production lines through data analysis, Manufacturing test alignment, and electrical design improvements Own technical leadership for electrical continuous improvement initiatives and mentor team members in high-impact design and validation work Partner with Mechanical, Firmware, Manufacturing and Quality teams to ensure design changes align with product requirements and meet regulatory and compliance standards QUALIFICATIONS: Bachelor's or Master's degree in Electrical Engineering or related field 10+ years of experience in electrical engineering with a focus on high-volume product development and manufacturing Deep understanding of EE fundamentals including analog, digital, and power systems Proven track record of driving electrical design improvements from concept through validation in production environments Strong experience with failure analysis methodologies and tools Experience working with and qualifying second sources for critical electrical components Excellent leadership, communication, and cross-functional collaboration skills Strong commitment to embracing and leveraging AI tools in day-to-day tasks, ensuring AI-assisted work aligns with the same high-quality standards as personal contributions BONUS QUALIFICATIONS: Experience in battery-powered, high-reliability products at scale. Experience with designing systems with BLE, NFC, PPG, ECG or USB subsystems Experience with PCB manufacturing technologies such as ELIC, HDI, FPC, and Rigid-Flex This role is based in the WHOOP office located in Boston, MA. The successful candidate must be prepared to relocate if necessary to work out of the Boston, MA office. Interested in the role, but don't meet every qualification? We encourage you to still apply! At WHOOP, we believe there is much more to a candidate than what is written on paper, and we value character as much as experience. As we continue to build a diverse and inclusive environment, we encourage anyone who is interested in this role to apply. WHOOP is an Equal Opportunity Employer and participates in E-verify to determine employment eligibility. It is unlawful in Massachusetts to require or administer a lie detector test as a condition of employment or continued employment. An employer who violates this law shall be subject to criminal penalties and civil liability. The WHOOP compensation philosophy is designed to attract, motivate, and retain exceptional talent by offering competitive base salaries, meaningful equity, and consistent pay practices that reflect our mission and core values. At WHOOP, we view total compensation as the combination of base salary, equity, and benefits, with equity serving as a key differentiator that aligns our employees with the long-term success of the company and allows every member of our corporate team to own part of WHOOP and share in the company's long-term growth and success. The U.S. base salary range for this full-time position is $165,000 - $210,000. Salary ranges are determined by role, level, and location. Within each range, individual pay is based on factors such as job-related skills, experience, performance, and relevant education or training. In addition to the base salary, the successful candidate will also receive benefits and a generous equity package. These ranges may be modified in the future to reflect evolving market conditions and organizational needs. While most offers will typically fall toward the starting point of the range, total compensation will depend on the candidate's specific qualifications, expertise, and alignment with the role's requirements.

Execute aseptic process simulations (APS) and support process validation activities, including documentation, execution, and result review. Develop and author validation protocols such as URS, IQ, OQ, and PQ in alignment with GDP and GMP standards. Perform equipment and analytical instrument qualification following regulatory and internal guidelines. Conduct automation and software compliance assessments to ensure adherence to 21 CFR Part 11 requirements. Coordinate cross-functional activities with engineering, quality, IT, vendors, and operations to complete CQV (Commissioning, Qualification & Validation) tasks. Support validation of automated manufacturing systems and sterile process controls. Maintain accurate, audit-ready validation documentation in compliance with quality system requirements. Participate in off-shift or weekend APS execution while maintaining a standard 40-hour workweek. Ensure all work aligns with applicable SOPs, regulations, and Good Documentation Practices (GDP).