Regulatory Compliance Engineer

Re:Build Manufacturing; Kalamazoo (MI); On-site; USD 70,000 - 95,000; Full time

Job summary

Re:Build Manufacturing, including Tekna, is seeking a Regulatory Compliance Engineer to support New Product Development under Tekna’s QA framework. The role focuses on product safety, efficacy, reliability, and regulatory compliance in a dynamic environment grounded in manufacturing and design services.

You will work with cross-functional teams to advance NPD, maintain DHF, and ensure quality processes across development and production.

Qualifications

• Bachelor of science degree in engineering is preferred.
• 1 to 3 years’ experience in Regulatory Compliance or 5+ years in new product development is preferred.
• Proficiency in statistical analysis and control is preferred.
• Organizational skills are important.

Responsibilities

• Support Core Leadership on NPD projects and mentor other compliance engineers.
• Assist in creating a Design History File and ensure QMS conformance.
• Develop project plans to optimize product quality, schedule and cost.
• Research product requirements and lead risk management activities.
• Coordinate PPAP processes with procurement and production teams.
• Support design transfer and verification testing activities.

Skills

Regulatory compliance

Statistical analysis

Organizational skills

Education

Bachelor of science degree in engineering

Job description

About Re:Build Manufacturing and Re:Build Tekna:

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.

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.

Who we are looking for

If you like a dynamic setting where individuals can grow and face diverse projects, we offer great variety. We empower staff to take on as much responsibility as they can handle. We provide mentorship and support from a highly proficient team. Our goal is to enable our employees to reach their highest capabilities, and through our association with Re:Build, provide avenues for personal and professional growth.

The Regulatory Compliance Engineer is responsible to complete tasks as directed by Tekna’s quality assurance framework. This supports New Product Development and ensures product safety, efficacy, reliability, and compliance with 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 affirmative 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.

This position requires access to export-controlled information. To comply with U.S. export control regulations, applicant must be a U.S. citizen, lawful permanent resident, refugee, asylee, or eligible to obtain the required export authorizations. Are you a U.S. citizen, lawful permanent resident, refugee, or asylee?

Are you authorized to work for any employer in the United States?

Do you today or at any point in the future require visa sponsorship for employement in the United States?

This is an onsite role. You must be currently located in or commutable to Kalamazoo or relocating there. Are you currently living in or planning to relocate to Kalamazoo? (Relocation assistance is not offered)

Do you have 3+ years in corporate or consulting environments working closely with Design and Engineering teams to scope projects to gain an understanding for clients’ business objectives?

Voluntary Self-Identification

For government reporting purposes, we ask candidates to respond to the below self-identification survey.Completion of the form is entirely voluntary. Whatever your decision, it will not be considered in the hiringprocess or thereafter. Any information that you do provide will be recorded and maintained in a confidential file.

As set forth in Re:Build Manufacturing’s Equal Employment Opportunity policy,we do not discriminate on the basis of any protected group status under any applicable law.

If you believe you belong to any of the categories of protected veterans listed below, please indicate by making the appropriate selection.As a government contractor subject to the Vietnam Era Veterans Readjustment Assistance Act (VEVRAA), we request this information in order to measurethe effectiveness of the outreach and positive recruitment efforts we undertake pursuant to VEVRAA. Classification of protected categoriesis as follows:

A "disabled veteran" is one of the following: a veteran of the U.S. military, ground, naval or air service who is entitled to compensation (or who but for the receipt of military retired pay would be entitled to compensation) under laws administered by the Secretary of Veterans Affairs; or a person who was discharged or released from active duty because of a service-connected disability.

A "recently separated veteran" means any veteran during the three-year period beginning on the date of such veteran's discharge or release from active duty in the U.S. military, ground, naval, or air service.

An "active duty wartime or campaign badge veteran" means a veteran who served on active duty in the U.S. military, ground, naval or air service during a war, or in a campaign or expedition for which a campaign badge has been authorized under the laws administered by the Department of Defense.

An "Armed forces service medal veteran" means a veteran who, while serving on active duty in the U.S. military, ground, naval or air service, participated in a United States military operation for which an Armed Forces service medal was awarded pursuant to Executive Order 12985.