Senior R&D Engineer
Wellspect AB · Mölndal · Tills vidare · Deadline 2027-01-02
Wellspect AB is seeking a **Senior R&D Engineer** for medical device product development, based at their site in Mölndal. This is an **on-site position** where the engineer leads mechanical design development across innovation, new product development, and product care projects. Working with cross-functional teams, responsibilities include owning technical requirements and specifications, driving design for manufacturing (DFM), creating CAD models and drawings using Creo and Windchill, and planning design verification and validation. The role also involves participating in risk management under ISO 14971, ensuring regulatory and Design Control compliance, acting as a subject matter expert, and supporting industrialization and supplier collaboration. Candidates must hold a **B.Sc. or M.Sc. in Mechanical Engineering or equivalent** and bring at least **10 years of product development experience**. Strong expertise in injection-molded plastic parts, polymer materials, and their manufacturing processes is required, alongside solid modeling and PDM experience, and excellent English communication skills. Prior experience in medical devices, ISO 13485, Design Control, and design transfer is strongly preferred.
Senior R&D Engineer - Medical Device Product Development
Are you passionate about creating innovative medical devices that improve people's lives and shape the next generation of medical devices?
We are looking for a highly experienced Mechanical Design Engineer with strong expertise in injection-molded plastic parts, polymer materials, and medical device development. You will be an important part of our R&D team, driving development from concept through industrialization and product launch supporting growth of our medical device portfolio.
We passionately strive to make a real difference every day to everyone who needs our products and services.
We can offer you an exciting and challenging job in a company that is committed to making a difference every day. We have a culture of team spirit where sharing knowledge and finding new ways to tackle challenges together is key. In this role you will work with many different cross-functional teams, and we can promise you a challenging learning journey.
What You Will Do
- Lead mechanical design development within innovation, NPD and product care projects.
- Own technical requirements, specifications and design solutions.
- Drive device design and DFM activities.
- Develop CAD models and drawings using PCT(Creo) and Windchill.
- Plan and execute design verification and validation activities.
- Ensure compliance with Design Control and regulatory requirements.
- Contribute and act as Subject Matter Expert(SME) for assigned task within department
- Participate in risk management activities according to ISO 14971.
- Support industrialization, design transfer and supplier collaboration.
Who You Are
- Creative and innovative problem solver.
- Strong cross-functional collaborator.
- Results-oriented with a proactive mindset.
- Excellent communicator in English.
- Well structured, and confident in mechanical engineering tools
Qualifications
- B.Sc. or M.Sc. in Mechanical Engineering or equivalent.
- Minimum 10 years of product development experience.
- Strong expertise in injection molding and polymer materials and their manufacturing processes.
- Medical device experience is strongly preferred.
- Experience with ISO 13485, Design Control and Design Transfer, DFM.
- Strong experience in solid modeling(CAD) and working in PDM environment
Why Join Wellspect?
- Meaningful work improving quality of life.
- Opportunity to influence future innovations.
- Collaborative culture and skilled colleagues.
- Flexible and supportive work environment.
Location: Mölndal, Sweden (on-site position)
Applications are reviewed continuously,
We look forward to hearing from you!