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
The Advanced Quality Engineer completes tasks as guided by Re:Build Kalamazoo's quality assurance framework. This supports New Product Development and helps ensure product safety, efficacy, reliability, and conformity with applicable regulatory requirements. Quality Engineers are assigned to individual projects and stay with them from product development through production launch.
We're looking for someone with hands-on PFMEA and DFMEA experience and a PPAP background. You look at the intent of a process, not just the letter of it. You're comfortable coaching suppliers who are still learning these methods.
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.
Read blueprints
Computer literacy
Problem solving skills
Communication skills
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 accommodations.ta@ReBuildmanufacturing.com or you may call us at 617.909.6275.
