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• C

  Director of R&D  

  Cypress HCM

  full_time - New Hope

  Posted: 11/09/2025

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  Job DescriptionJob DescriptionDirector of R&D – Medical Devices New Ho... Read More

  Job DescriptionJob DescriptionDirector of R&D – Medical Devices
  New Hope, MN
  Full-Time | $150,000–$200,000 + Bonus + Stock Options
  A leading medical device company in the Twin Cities is seeking a Director of Research & Development to lead innovation and growth at its New Hope facility. This critical leadership role will oversee a team of approximately 30 engineers, with a strong focus on advancing catheter technologies from concept through to design transfer and manufacturing readiness.We're looking for a hands-on, strategic R&D leader with deep experience in contract manufacturing and medical device development—someone who can both inspire high performance and dive into the technical details alongside the team when needed.
  Key ResponsibilitiesLead, mentor, and grow a high-performing R&D engineering team.Recruit and retain top talent while fostering a collaborative, innovation-driven culture.Drive the full lifecycle of catheter development—conceptualization, design, validation, and transfer to manufacturing.Ensure robust product and process development in line with regulatory and customer requirements.Champion cross-functional collaboration to ensure seamless product integration into Operations.Identify and propose new technologies to enhance technical capabilities and business growth.Guide the team through process validation strategies (IQ, OQ, PQ).Support budget planning, project scheduling, and strategic decision-making for R&D initiatives.QualificationsBachelor’s degree in Mechanical, Biomedical, or related Engineering discipline.Minimum 5 years of experience in catheter or medical component development and manufacturing.At least 7 years in a leadership role within an R&D or engineering environment.Proven track record with FDA regulations, design controls, GMP, GDP, and QMS standards.Experience with budgeting, scheduling, and organizational planning.Strong understanding of product and process design within a regulated environment Read Less

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• C

  Senior Quality Engineer - NPD  

  Cypress HCM

  full_time - Forest Lake

  Posted: 23/04/2025

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  Job DescriptionJob DescriptionA contract manufacturing client in Fores... Read More

  Job DescriptionJob DescriptionA contract manufacturing client in Forest Lake, Minnesota is hiring a Senior Quality Engineer in their defense sector. This role is responsible to lead new product development programs to production approval by working with customers and program management, ensuring robust processes and documentation are developed and a successful transfer to production. This person needs to be onsite 5 days a week and will report to the Director of PMO.
  Must Haves: Preferred Bachelor’s degree in engineering or related field, or equivalent experience in a contract manufacturing environment, preferably in regulated industries. 8 years of experience in quality 2 years in plastic injection molding.Essential Functions:Work cooperatively with all employees in a team environment Serve as the quality representative on cross-functional new product development teams.Review all documents and specifications referenced on the drawing or purchase orders, identify concerns and communicate to the cross-functional new product development team. Drive drawing and specification changes needed to effectively transfer projects to production.Proactively lead and anticipate the needs of the customer and/or project and develop plans to mitigate risks encountered during the project.Respond in a timely and professional manner to internal and external customer requests that pertain to quality.Understand and follow regulatory requirements for FDA, ISO and Government standards.Develop and optimize validation protocols and execute reports to meet regulatory, customer and internal production requirements.Develop inspection plans, fixtures and methods to achieve quality requirements and standards, document quality issues identified during development and to ensure best practices are implemented.Work closely with the metrology team to schedule and drive product first article inspections, capability studies, gage R&Rs, etc. Review data to ensure accuracy for submission to customers.Investigate and determine root cause of product quality issues and defects for new products and implements solutions to resolve issues; assist other personnel, as required, with the Corrective Action processEstablish and execute priorities for multiple programs of varying complexity to achieve customer expectations based on new product development schedules established by the program management team.Drive continual improvement in regard to procedures, processes, work flow, compliance to standards, and to ensure product quality.Provide project knowledge and insight to Sustaining Engineers and support production issues as needed.Responsible for performing internal audits, as required, based on internal audit schedule.Mentor and provide guidance, in regard to quality and project related issues, to less experienced team members to drive personal and professional growth of the team, timely and appropriate resolution of issues.Proactively identify gaps, and potential solutions to resolve them, in existing equipment, resources and technology to ensure the quality team is well-positioned to address ever-changing market and customer needs.Other tasks as assigned by supervisorSalary of $80 - 120K Annually + bonus Read Less

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