Advanced engineer jobs in Medford, MA

Nationwide Opportunities Do you thrive on optimizing systems, improving yields, and driving operational excellence? Whether your background is in pharma, biotech, medical device, or advanced manufacturing, we'd love to connect. At Scientific Search, we partner with industry leaders and emerging innovators across the U.S. who rely on talented Process Engineers to enhance production efficiency, scale technologies, and ensure consistent product quality. We're continually supporting new searches and always expanding our network of process professionals. We're Interested In Connecting With Engineers Experienced In Process development, scale-up, and optimization Equipment design, installation, and validation Root cause analysis, troubleshooting, and continuous improvement (Six Sigma, Lean) cGMP manufacturing support within regulated environments Cross-functional collaboration with operations, quality, and R&D teams If you'd like to be considered for future Process Engineer roles, please send us your resume. We'll keep you in mind as new positions arise that fit your expertise, interests, and preferred locations. Submit your resume We're always growing our network of skilled Process Engineers - let's stay connected so we can help you discover the right opportunity when the time is right. #19580

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.

Vaxess is a NIH and venture-funded company developing a pipeline of next-generation vaccines and therapeutics on the MIMIX platform. With only five minutes of wear-time on the skin, the self-applied MIMIX patch enables up to two weeks of sustained delivery. The platform combines high 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. Research & development at Vaxess is cross-disciplinary, integrating mechanical, industrial, biomedical, and chemical engineering with chemistry, biology, and human factors to address important unmet medical needs. We are seeking a talented, collaborative, and highly motivated engineer to join our growing team. This role offers a unique opportunity to build manufacturing capacity from the ground up to bring innovative technology to theglobal vaccine and therapeutic market. 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 Vaxess is building a team of exceptional people to rapidly advance product development. We work closely as a team and thrive in a dynamic, exciting, and engaging work environment. If you're interested in joining the Vaxess team, please submit your CV/resume to ******************.

Job Title: Manufacturing Engineer Pay Rate: $32.00-$55.00/hour (DOE) direct with full benefits Shift: 1st #ManufacturingEngineer #AerospaceManufacturing #MRBEngineer Job Overview: We are seeking a Manufacturing Engineer with a strong foundation in aerospace or precision manufacturing environments to provide centralized engineering support. This role is focused on mitigating overflow capacity and supporting high-priority military production programs. The ideal candidate will have hands-on experience with material disposition, MRB processes, and quality-driven manufacturing practices. This is a high-impact opportunity to contribute to the delivery of high-stress rotating components and aerospace parts. Responsibilities: * Drive Material Review Board (MRB) processes: submit, track, and clarify MRB cases, particularly related to aged Work-In-Progress (WIP). * Facilitate decision-making around WIP disposition: repair, scrap, or rework. * Track and document aged WIP across manufacturing cells. * Gather Root Cause Corrective Actions (RCCA) and collaborate with stakeholders to close quality loops. * Assist with shop floor engineering support and general process improvement initiatives. * Support general rework using machining equipment such as lathes, milling machines, and grinders. Core Qualifications: * 1+ year of experience in a manufacturing environment (aerospace preferred). * Familiarity with rotating parts, tight-tolerance machining, or high-stress aerospace components. * Knowledge of MRB procedures and ability to work with quality teams to ensure compliance and resolution. * Hands-on experience with RCCA gathering and reporting. * Experience using metrology equipment (calipers, micrometers, dial indicators, drop gauges, optical comparators, linear trace machines). * Strong communication, organizational, and self-management skills. * Due to the nature of the work US Citizenship required. Preferred Traits & Skills: * Product Release Certification (PR) or eligibility to obtain is highly preferred. * Self-directed and proactive. * Comfortable with administrative tracking and technical documentation. * Flexible and open to evolving manufacturing priorities. * Passionate about quality, learning, and continuous improvement. Belcan provides a competitive pay and benefits package. Benefits offered MAY include health, dental, vision, and life insurance; 401(k); education assistance; paid time off including PTO, holidays, and paid leave required by law. Salary guidelines for similar roles at Belcan are $32.00-40.00 per hour. Guidelines vary based on many factors including but not limited to education, qualifications, experience, discipline, geographic location, market, and business considerations. EOE/F/M/D/V Build a challenging and rewarding career with an industry leader!

🚀 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.

MUST HAVE EXPERIENCE WITH VUE, Pinia/VUEX and application frameworks such as Nuxt.js/Next.js. Scientists around the world use Orion for early-stage drug discovery and design in the pursuit of improving human health. Orion combines the power of advanced HPC, computational methods, and in-browser 3D visualization & modeling to solve problems in drug discovery & design. Our innovative solutions enable customers to routinely model billions of compounds in-silico. Orion enables our customers to interactively explore chemical space, evaluate designs and gain scientific understanding. MUST HAVE EXPERIENCE WITH VUE, Pinia/VUEX and application frameworks such as Nuxt.js/Next.js. As a Principal UI Engineer, you will work with designers, scientists, and software engineers to enhance & extend Orion's UI capabilities. You'll have the chance to work on a multitude of interesting challenges across scientific visualization, collaboration, data management, as well as new product & feature development. You'll be part of a team building cutting edge features, as well as helping to modernize existing software. MUST HAVE EXPERIENCE WITH VUE, Pinia/VUEX and application frameworks such as Nuxt.js/Next.js. Minimum Qualifications: MUST HAVE EXPERIENCE WITH VUE, Pinia/VUEX and application frameworks such as Nuxt.js/Next.js. BS in computer science/engineering, biology/chemistry or similar with a minimum of 7 years of experience OR MS with a minimum of 5 years of experience OR PhD with a minimum of 1 year of experience Experience designing, developing, troubleshooting and debugging complex user interfaces and software systems as part of a team Expert in JavaScript/Typescript/CSS/HTML MUST HAVE EXPERIENCE WITH VUE, Pinia/VUEX and application frameworks such as Nuxt.js/Next.js. Experience in Life Sciences, HPC, Python, AWS, Web Workers, WebAssembly, and WebGL are a plus Experience with unit & end-to-end testing, CI/CD, source control, code review, comfortable using command line interfaces Strong background of computer science fundamentals (data structures, algorithms) Passionate to learn and explore new technologies and demonstrates good analysis and problem-solving skills Interpersonal skills required: Ability to establish a close working relationship with peers in development, science, design and customer success, often across time zones Take initiative to solve unexpected challenges during development Willing to expand their knowledge and skills in both technical and scientific areas Push to raise the bar while always operating with integrity OpenEye, Cadence Molecular Sciences, an industry leader in computational molecular design, uses a scientific approach to deliver rapid, robust, and scalable software, toolkits, and technology & design services for the advancement of pharmaceuticals, biologics, agrochemicals, and flavors

Job Title: Hardware/System Sustaining Engineer Details: Type: On-site Duration: Permanent Direct Hire Salary: $ Depending on Experience The Hardware Sustaining Engineer is responsible for supporting, maintaining, and improving existing hardware products throughout their lifecycle. This role bridges design engineering, component engineering, manufacturing, and quality to ensure product reliability, manufacturability, and continued compliance with standards. The role involves diagnosing hardware/system issues, instituting design updates, and designing and implementing automated product test applications. Key Responsibilities: Product Support & Maintenance Provide engineering support for released hardware products across their lifecycle. Investigate, troubleshoot, and resolve hardware failures in production, field, and customer environments. Develop and implement engineering change orders / product change notices (PCNs) to address design improvements, manufacturing improvements, and component obsolescence. Support supply chain in evaluating alternate components and managing end-of-life (EOL) parts. Manufacturing & Quality Interface Collaborate with manufacturing teams to resolve build and test issues. Support failure analysis, root cause identification, and corrective/preventive actions (CAPA). Work with design engineering and quality teams to maintain compliance with applicable safety, regulatory, and industry standards. Product Documentation Maintain and update design documentation, schematics, BOMs, and test procedures. Validate and verify design changes through lab testing and simulations. Define test plans for verification of new designs. Qualifications: Bachelor's degree in Electrical Engineering, Computer Engineering, or related field. 3-7 years of experience in hardware design, sustaining engineering, or manufacturing support. Strong knowledge of analog/digital electronics, PCB design, and system-level troubleshooting. Experience with lab equipment (oscilloscopes, logic analyzers, power analyzers, etc.). Familiarity with industry standards (UL, FCC, CE, ISO, etc.). Strong problem-solving and root-cause analysis skills. Excellent communication skills for cross-team collaboration and reporting. Preferred Skills: Experience with Python and manufacturing test scripting. Experience conducting DVT and reliability testing. Knowledge of supply chain and component lifecycle management. Hands-on experience with CAD tools (e.g., Altium, OrCAD) and PLM systems. Ability to work in fast-paced, cross-disciplinary environments. Compliance / Export Control: This position may include access to technology and/or software source code subject to U.S. export controls (including ITAR). Applicants will be required to provide information regarding citizenship/immigration status for compliance. The company may decline to proceed if authorization is required and cannot be obtained. Company Overview: Founded in 2010, Top Prospect Group was created with a focus on matching high-quality candidates with top clients while fostering an environment where success is shared by all. In 2023, the company was acquired by HW Staffing Solutions, expanding its service offerings to include technology and professional services. Qualified candidates are encouraged to apply immediately! Please include a clean copy of your resume, salary expectations, and any references in your application .

Country: United States of America Onsite U.S. Citizen, U.S. Person, or Immigration Status Requirements: 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 Security Clearance: DoD Clearance: Secret As a Principal Specialist, you'll be the Project Lead supporting repair contracts for both ground and missile systems to ensure repaired assets are returned to the customer in accordance with the financial and schedule limitations of the contract. In this role you'll execute in a highly dynamic environment as each repair needs to be individually tracked. You'll coordinate and collaborate with the repair performing locations and across functional areas like supply chain and finance to provide the current status of the repairs to program management and the customer. Work Location: Tewksbury, MA Additional responsibilities may include: Perform budget and schedule analysis for all repairs. Coordinate with supporting functions to move repair assets through the process. Consolidate and present weekly status of repairs, manage monthly contract deliverables. Prepare and present metrics and status at internal and external program reviews Qualifications You Must Have: Typically Requires: Bachelor's Degree and a minimum 5 years of relevant material acquisition, supply chain, logistics, operations, manufacturing, depot operations, engineering or maintenance experience. An advanced degree may account for additional years of experience as required for this position. Experience in program planning, budgeting, and tracking (EVMS) to cost and schedule Experience with logistics support, Repair & Return processes, or manufacturing. The ability to obtain and maintain a US security clearance. US citizenship is required as only US citizens are eligible for a security clearance. Qualifications We Prefer: Patriot System product knowledge and or experience Detail orientated and demonstrated ability to effectively work in a team Knowledge, understanding of FMS and DCS contract execution. Knowledge, understanding and application of PRISM, SAP, ARMS, APEX Self-initiative, strong written and oral communication skills Experience presenting data to audiences of varying sizes Proficiency with Microsoft Office products What We Offer Our values drive our actions, behaviors, and performance with a vision for a safer, more connected world. At RTX we value: Safety, Trust, Respect, Accountability, Collaboration, and Innovation. Learn More & Apply Now! Please consider the following role type definition as you apply for this role Onsite: Employees who are working in Onsite roles will work primarily onsite. This includes all production and maintenance employees, as they are essential to the development of our products. The salary range for this role is 82,000 USD - 164,000 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. 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

Our client is seeking a POS Quality Engineer to join their team! This position is located in Canton, Massachusetts. Execute functional testing for the client's POS systems in a lab environment Validate new POS features, patches, upgrades, and configuration changes Troubleshoot issues across POS hardware, networking, integrations, and payment systems Review logs, identify root causes, and escalate defects to internal teams and vendors Collaborate with vendors delivering POS products to ensure quality and readiness Support daily version testing, weekly releases, and continuous enhancements Maintain test cases, regression suites, and documentation Ramp up on the clients POS systems, environments, and workflows Execute manual testing independently and efficiently Understand integration points with kiosk, mobile apps, loyalty, and payments Build relationships with product, engineering, and vendor teams Contribute to expanding and maintaining POS test automation frameworks Improve test coverage, defect identification, and issue resolution speed Work independently with minimal oversight while communicating affectively Support performance-related testing for high-volume transaction scenarios Help streamline testing workflows to support frequent deployments Desired Skills/Experience: 5+ years of POS Quality Engineering experience Hands-on experience with any POS system such as: Aloha, Toast, NCR, Oracle Symphony, or other enterprise/custom POS systems Experience with payment systems such as: VeriFone, kiosk integrations, loyalty platforms, mobile ordering, and web integrations Strong manual testing proficiency with the ability to execute tests quickly and accurately Ability to troubleshoot logs, hardware, and light networking issues Experience collaborating with third-party vendors on POS deliverables Familiarity with automation frameworks and ability to contribute to automation improvements Prior experience working in a POS lab environment (devices, staging stores, simulators) Strong communication, organization, and self-management skills Benefits: Medical, Dental, & Vision Insurance Plans Employee-Owned Profit Sharing (ESOP) 401K offered The approximate pay range for this position is between $55.00 and $65.00. Please note that the pay range provided is a good faith estimate. Final compensation may vary based on factors including but not limited to background, knowledge, skills, and location. We comply with local wage minimums.

& Responsibilities The Senior Process Engineer 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 Process Engineer - 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 process engineering 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.

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

Must Have Technical/Functional Skills • Knowledge on Quality Management and its tools & techniques • Knowledge about GMP (Good Manufacturing Practices), FDA, ISO 13485 and compliance regulations • Knowledge on Medical Device Regulatory Standards, MDD and MDR • Knowledge on NC, CAPA, Root Cause Analysis and Audit processes • Knowledge on Validation process, writing protocols/ reports • Very good understanding/ experience in writing procedures, product specs and work instructions • Knowledge in Statistics, Risk Management and Design control • Must possess good communication skills (verbal and written), familiar with project management methodology, problem solving, and presentation skills • Experience in creating FMEAs & Writing reports • Experience in PMS (Post Market Surveillance) • Experience in PLM Tool (Windchill) • Good understanding of Design, Drawing and GD&T • Excellent Interpersonal / communication skills, Organizational / planning and Project management skills preferred • Personal computer skills, Windows: word processing, presentation, e-mail, web browsers & spreadsheet software • Ability to work efficiently, meet timelines, and communicate status (generate trackers, send emails, etc.) Roles & Responsibilities • Under limited supervision and in accordance with all applicable federal, state and local laws/regulations and Corporate Johnson & Johnson, procedures and guidelines, the duties and responsibilities for this position are: • Development and review of PDP (Product development Process) deliverables • Review and approve R&D/ Engineering protocol/ reports • Development of Risk management records (i.e. DFMEA/ PFMEA) in collaboration with SMEs • Support and provide guidance on Validations and if required write Validation Protocols/ Reports • Support/ Remediation of Validation/ Quality Documentation • Support Root Cause Investigation and closure of NC and CAPA • Review and approve the Change Orders (CR/ CN) • Review and update the design/ process control documents like procedures/ work instructions/ product specs etc. • Work with cross functional teams and internal teams to create deliverables • Performs other duties assigned as needed Salary Range: $90,000 $95,000 Year TCS Employee Benefits Summary: Discretionary Annual Incentive. Comprehensive Medical Coverage: Medical & Health, Dental & Vision, Disability Planning & Insurance, Pet Insurance Plans. Family Support: Maternal & Parental Leaves. Insurance Options: Auto & Home Insurance, Identity Theft Protection. Convenience & Professional Growth: Commuter Benefits & Certification & amp; Training Reimbursement. Time Off: Vacation, Time Off, Sick Leave & Holidays. Legal & Financial Assistance: Legal Assistance, 401K Plan, Performance Bonus, College Fund, Student Loan Refinancing.

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.

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 Title: Product Quality Engineer Duration: 5+ Months Minimum 1 year working with medical devices or other highly regulated industry, Quality Engineering experience preferred Organizational Relationships: Works with Divisional personnel and Costa Rica personnel including Product Quality Engineering (PQE), Post Market Quality Engineering (PMQE), and Post Market Analytics. Job Summary • Provide Product Quality Engineering support on risk management and product complaint trending. This role will be responsible for reviewing each complaint record individually and identifying the appropriate risk lines and associated severities from the product's Risk Management File (RMF) that relate to what was reported by the complainant and the results of the investigation. In partnership with Product Quality Engineering and Post Market Quality Engineering, the qualified contractor will perform assessments, identify potential updates to the RMF, and perform trend analysis per the applicable quality procedures. Essential Duties Duties are listed in order of greatest importance. The incumbent may be asked to perform other function-related activities in addition to the below-mentioned responsibilities as reasonably required by business needs. Analyze complaint information and identify hazardous situations and harms reported through complaint information Evaluating content in existing Risk Management Files ensuring all hazardous situations and harms reported through complaint information is adequately captured. Perform trend analysis using Statistical Process Controls per applicable quality procedures. Qualifications -Education • BS in biomedical engineering, mechanical engineering, or health care related disciplin -Experience Minimum 1 year working with medical devices or other highly regulated industry, Quality Engineering experience preferred - Skills Experienced with Quality System Regulations, ISO 13485 and 21 CFR 820. Experienced with ISO 14971, Risk Management Basic knowledge of risk analysis techniques such as FMEAs Basic knowledge of medical terminology and anatomy Basic knowledge of engineering and process terminology Understanding of statistics including statistical process control (SPC) - Minitab experience preferred Detail-oriented and committed to maintaining accuracy and compliance in all tasks Accountable and reliable, with a focus on timely communication and issue escalation Collaborative team player, open to receiving feedback and contributing to shared goal Ability to effectively work on project teams, including taking leadership role on critical tasks to assure appropriate and timely completion/resolution Ability to appropriately assess written product and project documentation, and ability to effectively communicate assessment - Preferred Experience authoring and executing risk assessments Working knowledge of ISO14971, 21 CFR 803 and 21 CFR 820

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.

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).

*Ensures maximum cost effectiveness and reliability of Gerotor manufacturing processes and workflow. Determines the methods and sequence of manufacturing operations for products and machine parts and assemblies; ensures that products and processes meet customer quality requirements. Provides producibility input and manufacturing plans for product design or modification. Essential Functions: * Evaluates manufacturing processes by conducting process analysis, applying knowledge of product design, fabrication, assembly, tooling, and materials, conferring with suppliers, and soliciting observations from operators/production technicians. * Performs problem solving and root cause analysis of manufacturing issues. Recommends and implements effective corrective actions. * Develops manufacturing processes by studying product requirements; researching, designing, modifying, and testing manufacturing methods and equipment; and conferring with equipment suppliers. Prepares written and graphical work instructions for the communication of manufacturing requirements to production personnel. * Improves manufacturing efficiency by analyzing and planning workflow, space requirements, and equipment layout. Assures process control and reliability for assigned area(s). * Assures product and process quality by designing testing and inspection methods, testing finished product and process capabilities, and establishing standards to confirm and validate manufacturing process requirements. * Recommends changes to refine and enhance products and processes by applying continuous improvement and key lean manufacturing/production principles and techniques to areas of production. * Provides manufacturing decision-making information by calculating production, labor standards, and material costs, reviewing production schedules, and estimating future requirements. May provide on-site support to address technical issues at supplier base. * Prepares product and process reports by collecting, analyzing, and summarizing information and trends. * May provide concurrent engineering support and recommend manufacturing methods to the engineering design team. * May keep equipment operational by coordinating maintenance and repair services, following manufacturer's instructions and established procedures, and requesting special service. * May maintain product and process database by writing computer programs and entering data. * Maintains professional and technical knowledge by attending educational workshops, reviewing publications, establishing industry networks, benchmarking state-of-the-art practices, and participating in professional associations. * Complies with federal, state, and local legal requirements (e.g. environmental, safety, etc.) by studying existing and new legislation, ensuring adherence to requirements, and advising management on needed actions. * Contributes to team effort by accomplishing related results as needed. Work assignments may include cross- * functional or project team responsibilities (e.g. continuous improvement). Qualifications: * Bachelor's degree (BS) in Manufacturing Engineering or related engineering field. * Professional entry level position. * May have limited prior industry experience or worked with direction in student internship programs. * Society of Manufacturing Engineering (SME) or Mechanical Engineering (ASME) certification desired. * Fundamental knowledge of metallurgy and heat treatment of common aerospace materials. * Fundamental knowledge of lean manufacturing/production principles and techniques. * General knowledge of aerospace industry or similar industry products and legal and regulatory requirements related to manufacturing plants. Ability to use standard business applications software and/or specialized data analysis tools. * May be required to develop skills in drafting, programming, and CAD or other computer aided manufacturing systems. * Ability to research and analyze data and develop recommendations or resolve problems. * Ability to work with only general work direction and instructions regarding the scope of assignments, determine priority and order of assignments. * Ability to read, analyze, and interpret technical journals and reports. * Ability to respond to inquiries or complaints from team members, team leaders, customers, and regulatory agencies. * Ability to define problems, collect data, establish facts, and draw valid conclusions. * Ability to effectively demonstrate team member competencies and participate in goal-setting, performance feedback, and self-development activities.