Regulatory Compliance Engineer

Re:Build Manufacturing; Kalamazoo (MI); On-site; USD 70,000 - 100,000; Full time

Job summary

Re:Build Manufacturing Tekna seeks a Regulatory Compliance Engineer to support New Product Development and ensure regulatory compliance, product safety, reliability and quality. The role works within Tekna’s Quality Management System and across design, production, procurement and validation teams.

You will lead risk management activities, develop verification methods, and coordinate testing and PPAP with cross-functional teams to drive successful product launches.

Qualifications

• Bachelor of science degree in engineering.
• 1–3 years in Regulatory Compliance or 5+ years in New Product Development preferred.
• Proficiency in statistical analysis and control.
• Excellent organizational skills.

Responsibilities

• Support Core Leadership on NPD projects and mentor compliance engineers.
• Assist Project Manager with Design History File and QMS conformity.
• Create and manage project plans to optimize quality, schedule and cost.
• Research and establish product requirements and regulatory alignment.
• Lead risk management and document Risk Management reports for product launches.
• Support Production Engineer with 6M analysis for production processes.
• Assist Procurement with supply chain management and PPAP.
• Support Design and Production Engineers with FMEA (FMECA).
• Ensure basic safety standards are met and conduct DFM analyses.
• Assist in process flow and layout documentation and verification testing.

Skills

Regulatory Compliance

NPD

Quality Management

Statistics

Education

B.S. in Engineering

Job description

About Re:Build Manufacturing and Re:Build Tekna:

Tekna was founded in 1988 in the heart of Southwest Michigan where creative vision and hard work laid the foundation for a business that continues to grow in a rapidly evolving industry. The rigor and attention to detail that comes with designing for the medical industry has awarded us success in supporting both major companies and start-ups from early stage development to commercialization. The same principles apply as we’ve expanded to serve customers in a wide variety of other industries including consumer and industrial goods, electronics, and appliances. Tekna’s project portfolio is incredibly diverse covering medical, life science, consumer and industrial product categories. Tekna is largely client focused offering design consulting, contract manufacturing and original equipment manufacturing services. Tekna’s cross functional teams include Design Engineering, Industrial Design, CAD, Procurement, Production and Quality which offers a friendly and supportive team atmosphere.

Re:Build Manufacturing is a growing family of industrial and engineering businesses combining enabling technologies, operational superiority, and strategic M&A to build America’s next generation industrial company. At Re:Build we deploy deep expertise in engineering, operations management, and technology to supercharge the performance of our member companies. We leverage deep professional expertise and a candid, principled operating culture to drive differentiated outcomes. Ours is a fast-paced environment where individuals can stretch and be challenged to pursue their fullest potential.

Re:Build was founded to pioneer a profitable model for the revitalization of US manufacturing. We’ve assembled a powerful set of complimentary capabilities and lines of business that enable us to pursue a wide range of end markets. Our acquired businesses are grounded in build-to-print and by-the-hour engineering and design services, and we’re leveraging their combined expertise to migrate to increasingly sophisticated program development and production, as well as the generation of our own products. Our unique set of capabilities lend themselves to highly complex systems and products, and we offer customers a range of services including product and systems design, automation, fabrication, assembly, and large volume contract manufacturing. Our customers span a wide array of industries including aerospace, defense, mobility, healthcare, pharma, biotech, clean tech, chemicals, energy, lifestyle, food production, and industrial equipment.

Who we are looking for

If you like a fast-paced environment where individuals can stretch and be challenged with a diverse set of projects, we offer a great deal of variety and empower our staff to take on as much responsibility as they can handle, offering a helping hand and experienced-based coaching and the support of a highly competent team. Our goal is to enable our employees to achieve their fullest potential, and through our association with Re:Build, provide avenues for personal and professional growth.

The Regulatory Compliance Engineer is responsible to execute tasks as directed by Tekna’s Quality Management System in support of New Product Development and to ensure product safety, efficacy, reliability, and compliance to applicable regulatory requirements.

What you'll get to do

• Support the Core Leadership role on NPD projects. Delegate and provide mentorship of other compliance engineers assigned to your NPD projects.
• Support the Project Manager in the creation of a Design History File and ensure conformance/compliance with the Quality Management System.
• Initiate and maintain project plans that optimize product quality, project schedule, and project/product cost per the Master Project Plan.
• Conduct necessary research and establish product requirements.
• Lead risk management and coordinate the Risk Management Board review. Complete the Risk Management report required to achieve product launch.
• Support the Production Engineer, typically an Advanced Manufacturing Engineer (AME), with 6M analysis as part of developing the production process.
• Support the Procurement Specialist with supply chain management and PPAP.
• Support the Design Engineer and Production Engineer with Failure Mode and Effects Analysis (FMECA).
• Overwatch design for basic safety requirements ensuring compliance with applicable safety standards.
• Conduct Design for Manufacturing Analysis.
• Support the Production Engineer in completing Process Flow and Layout Diagrams.
• Design and develop verification processes/procedures for incoming, in-process, and final inspection in support of the established production process.
• Support the Production Engineer in completing the Process verification and validation matrix.
• Support the Production Engineer in completing process qualification (installation qualification, operational qualification, and performance qualification) achieving Cpk/Ppk objectives.
• Support the Design Engineer in setting up and qualifying in-house verification test methods and coordinating 3rd party certification testing in compliance with applicable standards/regulations.
• Support design transfer from NPD DHF to Operations PDM.

What you bring to the team

• Bachelor of science degree in engineering preferred.
• 1 to 3 years’ experience in Regulatory Compliance or Advanced Quality and/or 5 or more years’ experience in new product development preferred.
• Proficiency in statistical analysis and control preferred.
• Organizational skills

We want to work with people that reflect the communities in which we operate

Re:Build Manufacturing is proud to be an Equal Employment Opportunity and Affluent Action employer. We do not discriminate based upon race, color, religion, gender, gender identity or expression, sexual orientation, national origin, genetics, disability, age, veteran status, marital status, parental status, cultural background, organizational level, work styles, tenure and life experiences. Or for any other reason.

Re:Build is committed to providing reasonable accommodations for qualified individuals with disabilities in our job application procedures. If you need assistance or an accommodation due to a disability, you may contact us at [e-mail] or you may call us at 617.909.6275.

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