Regulatory Compliance Engineer

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.

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.

• 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…