Reliability engineer jobs in Lawrence, MA

The Manufacturing Quality Engineer will be highly involved in the manufacturing aspects of the business, with an emphasis on Quality. The Quality Engineer will handle multiple projects and tasks throughout product development, product launch, and manufacturing. Additionally, this individual will ensure that product meets quality standards consistent with customer and other regulatory requirements. This role also supports plant activities in customer issues, supplier issues, and initiate corrective actions with an emphasis on process improvement. The mission of the Manufacturing Quality Engineer is to enhance the quality of materials and products through detection, analysis, and correction of conditions leading to nonconformance. Job Functions: Support, maintain, and sustain QMS. Audit processes and products. Complete first piece inspection activities. Support CMM programming needs. Support incoming inspection and communicate with suppliers regarding SCARS and other issues. Confer with engineers about the quality assurance of new products and development of procedures and quality requirements. Develop and update PFMEAs and Control Plans, as necessary. Assist in resolving customer quality issues. Investigate nonconformance reports and coordinate corrective / preventive actions. Perform internal audits and mentor process owners toward improvement. Participate on improvement teams for safety, quality, or cost. Collect and analyze internal/external quality data and report. Perform other duties as assigned to support the advancement of quality systems and operations. Skills: Good team player. Good problem-solving skills. Effective communication skills. Strong computer skills and knowledge of MS Office Suite. Working knowledge of print and specification interpretation. Required Experience: BS in Mechanical Engineering, or another technical field. 2+ year experience in Quality or Manufacturing background in diecast or injection molded products. Hands on experience measuring with various gauges and tools. Experience in 5S, lean or other continuous improvement methods. PPAP, QMS, NADCAP, and ISO9001 standards experience CMM Programming experience highly desired.

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: 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 .

*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.

🚀 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.

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

& 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.

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.

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.

Title: Engineer III - NPI Manufacturing Duration: 6 months+ (possible extension) Shift: Monday-Friday (8:00 am- 5pm) Responsibilities: Lead PFMEA activities in coordination with product development, quality, and manufacturing engineering teams. Participate in DFM and DFA activities to define manufacturing processes for new product and product enhancement programs. Develop manufacturing assembly and test methods to ensure Critical to Quality (CTQ) requirements are met. Must haves: Bachelors Degree at a Minimum Only Candidates with a Medical Device Background 5+ years of experience working in an FDA/ISO regulated medical device/medical equipment manufacturing environment. Must have prior NPI Manufacturing and/or Process Development experience, including disposables and capital equipment. Test Method Validation and Verification (TMV, V&V)

Cost Manufacturing Engineer - PERM role US Citizen Education & Experience Bachelor's degree in manufacturing, Mechanical, Industrial Engineering, or related discipline (or equivalent experience). 5-7 years of related experience in cost engineering, estimating, or manufacturing operations. Knowledge of metal stamping, heat treating, plating, welding, mechanical assembly, and CNC machining preferred. Proficiency in ERP systems (Syteline or similar), Microsoft Excel, SolidWorks, Outlook, and MS Project. Job Duties Utilize cost methodologies and tools to prepare and maintain reliable and accurate cost data. Identify and quantify potential cost uncertainties to ensure costing models capture the full range of risks. Establish cost estimates for production processes and tooling; review alternatives and recommend improvements. Track actual costs against estimates and report regularly to ensure alignment with forecasts. Investigate and identify cost reduction opportunities through detailed cost analysis. Contribute to cost monitoring and reporting systems; analyze cost trends and variances. Review monthly manufacturing variance reports to analyze deviations and adjust costs as needed. Coordinate with project management, engineering, procurement, and other stakeholders to ensure cost objectives are met. Analyze technical documents, blueprints, and vendor quotations to develop detailed cost estimates

The Product Quality Engineer II will be responsible for quality assurance activities including product quality engineering, non-conforming material report write ups and investigation, statistical process control, process improvements, and quality control oversight. Essential Duties and Responsibilities: Develop and maintain strong internal working relationships across restor3d. Understand the objectives, responsibilities, and mission of the Quality department and work towards those goals. Prioritize and plan work activities; adapt for changing conditions. Assist in maintaining the quality system in accordance with applicable regulatory requirements. Identify quality system process improvements and implement solutions. Lead or assist with the Corrective Action/Preventive Action (CAPA) program. Lead or assist with the Customer Complaint system by performing complaint investigations, including root cause analysis. Assist with product inspections as needed. Perform Internal Quality Audits of the quality system Participate in supplier selection and approval process, including leading supplier audits and review of quality data. Perform investigations of non-conformances and drive corrective actions. Participate on cross-functional product development teams. Participate in product/process validations. Perform risk assessments, gathering cross-functional team input. Employ statistical techniques and rationale in decision-making activities driven to support non-conformance trending, CAPA effectiveness, part qualification, and process monitoring. Establish and trend quality metrics and data. Participate in third party audits against ISO 13485 and FDA 21 CFR Part 820 requirements. Other responsibilities as assigned. Qualifications: Bachelor of Science in Engineering, Science, or Biomedical. 2+ years of Quality Assurance/Quality Engineering experience in the medical device industry and/or experience in an FDA regulated environment is required. Knowledge of FDA 21 CFR Part 820 and ISO 13485, preferred. ASQ certification (Certified Quality Engineer, Certified Quality Auditor, Certified Biomedical Auditor) a plus. Skills, Abilities, Competencies Required: Excellent written and verbal communication skills. Able to work accurately in a fast-paced, hectic, ever-changing environment with strong attention to detail. Demonstrated ability to monitor own work to ensure quality, accuracy, and thoroughness. Strong organizational, analytical, and time-management skills. Able to self-motivate and work both independently and as part of a team. Must have a solid knowledge of Microsoft office. Must be able to work in a team environment, execute responsibilities with minimal direct supervision, and have a high attention to detail. Demonstrated proficiency with FDA and ISO standards for Medical Devices. Restor3d is an Equal Opportunity Employer

Are you ready to see your future take flight? At GE Aerospace, we are advancing aviation technologies for today and tomorrow. Your work will contribute to the production of advanced jet engines, components, and integrated systems that power commercial and military aircraft. You'll be part of a team that embraces your drive, your curiosity, and your unique ideas and perspectives. Most importantly, you'll share in our pride and purpose that affects the lives of millions around the world! The Product Quality Engineer for the Airfoil Castings manufacturing process will drive product qualifications and quality improvements for key performance indicators (KPIs) of suppliers within the Airfoil Castings supply chain including quality plan implementation. The PQE, will own supplier First Article Inspection results and drive supplier compliance to Source Substantiation Plans or design intent verification. Provide supplier product release direction when part approval cycles are not complete while also being the internal quality focal for those parts. Collaborate with Supplier Quality, Supplier Quality Operations and New Product Introduction / Management of Change teams as required- this collaboration may include onsite visitation. In this role, you will also understand how the team integrates with other teams outside of Quality to meet short term and long term the business objectives. Demonstrate an in-depth understanding of key business drivers; uses this understanding to accomplish own work. In-depth understanding of how work of own team integrates with other teams and contributes to the area. **Job Description** **Roles and Responsibilities** + Role is responsible for supplier processes, from initial qualification, maintenance, and necessary improvement driven by business quality needs. + Product Quality Engineer will have a technical understanding of engineering drawings and will have the ability to manage suppliers and/or quality projects related projects. + Develop in-depth knowledge of a discipline. Use prior experience and acquired expertise to execute functional policy/strategy. + Communication with direct colleagues and the business on the status of First Article Inspection and Source Substantiation Plans. + Provide onsite support at suppliers, as needed ( **approximately 15% travel** ) + Collaboration with other Engineering, Quality, and Sourcing functions to ensure joint success + Impacts projects, processes, and procedures in own field. The role operates with some autonomy but is focused on execution of activities/provision of advice within an enabling discipline covered by standard functional practices and procedures. Activities require professional judgment but may require more senior levels of guidance. + Utilizes technical expertise and judgement to solve problems. Leverages technical skills and analytic thinking required to solve problems. May use multiple internal sources outside of own team to arrive at decisions. + Uses high level of judgment to make decisions and handle complex tasks or problems in areas of operational, product management, manufacturing, technology, or engineering. Has ability to assess quality of information given and ask pertinent questions to stakeholders. Able to offer new solutions to problems outside of set parameters and can construct and provide recommendations. Uses multiple internal and some external sources outside of own function to help arrive at a decision. + May lead functional teams or projects with minimal resource requirements, risk, and/or complexity. Communicates difficult concepts and may influence others' options on specific topics. May guide others to consider a different point of view. **Required Qualifications** + Bachelor's Degree from an accredited college or university (or a high school diploma/GED with 4 years' experience in Engineering, Materials Science or Quality related roles) + Minimum of 3 years of experience in Engineering, Materials Science or Quality related roles **Desired Characteristics** + Demonstrated experience in manufacturing or supplier quality. + Strong communication skills. + Demonstrated ability to analyze and resolve problems. + Ability to document, plan, market, and execute programs. + Established project management skills. + Demonstrated history of problem solving, root cause and corrective action methodology, data analysis, statistical analysis and quality experience. + Humble: respectful, receptive, agile, eager to learn + Transparent: shares critical information, speaks with candor, contributes constructively + Focused: quick learner, strategically prioritizes work, committed + Leadership ability: strong communicator, decision-maker, collaborative + Problem solver: analytical-minded, challenges existing processes, critical thinker + Demonstrated Airfoil Casting manufacturing knowledge and experience is advantageous to the role. 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 100,000.00 - 115,000.00. 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 **November 30th, 2025.** _This role requires access to U.S. export-controlled information. Therefore, employment will be contingent upon the ability to prove that you meet the status of a U.S. Person as one of the following: U.S. lawful permanent resident, U.S. Citizen, have been granted asylee or refugee status (i.e., a protected individual under the Immigration and Naturalization Act, 8 U.S.C. 1324b(a)(3))._ **Additional Information** GE Aerospace offers a great work environment, professional development, challenging careers, and competitive compensation. GE Aerospace is an Equal Opportunity Employer (****************************************************************************************** . Employment decisions are made without regard to race, color, religion, national or ethnic origin, sex, sexual orientation, gender identity or expression, age, disability, protected veteran status or other characteristics protected by law. GE Aerospace will only employ those who are legally authorized to work in the United States for this opening. Any offer of employment is conditioned upon the successful completion of a drug screen (as applicable). **Relocation Assistance Provided:** No \#LI-Remote - This is a remote position GE Aerospace is an Equal Opportunity Employer. Employment decisions are made without regard to race, color, religion, national or ethnic origin, sex, sexual orientation, gender identity or expression, age, disability, protected veteran status or other characteristics protected by law.

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. 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. Belcan is an equal opportunity employer. Your application and candidacy will not be considered based on race, color, sex, religion, creed, sexual orientation, gender identity, national origin, disability, genetic information, pregnancy, veteran status or any other characteristic protected by federal, state or local laws.

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.

The Product Quality Engineer I will be responsible for quality assurance activities including product quality engineering, non-conforming material report write ups and investigation, statistical process control, process improvements, and quality control oversight. Essential Duties and Responsibilities: Develop and maintain strong internal working relationships across restor3d. Understand the objectives, responsibilities, and mission of the Quality department and work towards those goals. Prioritize and plan work activities; adapt for changing conditions. Assist in maintaining the quality system in accordance with applicable regulatory requirements. Identify quality system process improvements and implement solutions. Assist with the Corrective/Preventive Action (CAPA) program. Assist with the Customer Complaint system by performing complaint investigations, including root cause analysis. Assist with product inspections as needed. Perform Internal Quality Audits of the quality system Participate in supplier selection and approval process, including supplier audits and review of quality data. Perform investigations of non-conformances and drive corrective actions. Participate on cross-functional product development teams. Participate in product/process validations. Perform risk assessments, gathering cross-functional team input. Establish and trend quality metrics and data. Participate in third party audits against ISO 13485 and FDA 21 CFR Part 820 requirements. Other responsibilities as assigned. Qualifications: Bachelor of Science in Engineering, Science, or Biomedical. 3 months to 2 years of Quality Assurance/Quality Engineering experience in an FDA regulated environment - preferably QSR (21 CFR Part 820) Skills, Abilities, Competencies Required: Excellent written and verbal communication skills. Able to work accurately in a fast-paced, hectic, ever-changing environment with strong attention to detail. Demonstrated ability to monitor own work to ensure quality, accuracy, and thoroughness. Strong organizational, analytical, and time-management skills. Able to self-motivate and work both independently and as part of a team. Must have a solid knowledge of Microsoft office. Must be able to work in a team environment, execute responsibilities with minimal direct supervision, and have a high attention to detail. restor3d is an Equal Opportunity Employer

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!

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).