Senior Engineering Project Manager – Manufacturing Development & Product Engineering
We are looking for an experienced engineering professional to help drive this journey. You will report to the COO.
The Role
As Senior Engineering Project Manager, you will play a key role in Vivostat’s technology and manufacturing development initiatives.
Your initial focus will be the commissioning, implementation and qualification of our second-generation manufacturing equipment, supporting the continued evolution of our assembly and device manufacturing processes. As manufacturing is outsourced to external partners, you will work closely with equipment suppliers, contract manufacturers, operations, and quality teams to lead activities from requirements definition through validation and implementation.
Longer term you will also lead and support engineering projects related to upgrades and enhancements of our existing PRO/APL medical device platforms. Working with external development and manufacturing partners as well as internal stakeholders, you will manage activities from requirements definition and design changes through verification, validation, regulatory assessment and design transfer, ensuring compliance with MDR, ISO 13485, and Design Control requirements.
This is a hands-on role in a small, collaborative organization, requiring strong project management and execution skills and the ability to coordinate external partners while engaging with technical details across manufacturing and product development.
Key Responsibilities- Lead commissioning, implementation and qualification of new manufacturing equipment.
- Manage collaboration with machine builders, development partners, and contract manufacturing partners.
- Plan and execute qualification and validation activities, including URS, risk assessments, and FAT, SAT, IQ, OQ, and PQ documentation
- In collaboration with QA, establish and manage Design & Development Plans in compliance with Design Control requirements, coordinate design reviews, risk management, verification, validation, and design transfer activities, and participate in maintaining technical files
- Support manufacturing process improvements, technology upgrades, and transfer activities where applicable.
- Ensure compliance with MDR, ISO 13485, ISO 14971, and Design Control requirements in collaboration with QA.
- Act as a key interface between R&D, Quality, Regulatory Affairs, Operations, and external partners.
Qualifications
You bring strong technical expertise combined with proven project leadership experience:
- Degree in Mechanical Engineering, Manufacturing Engineering, Industrial Engineering, or a related discipline.
- 5-10 years of experience in manufacturing equipment development, implementation, and qualification, with expertise in manufacturing systems, assembly processes, and automation within the medical device industry.
- Strong supplier and external partner management experience.
- Experience supporting or leading medical device development projects under Design Control.
- Solid knowledge of MDR, ISO 13485, ISO 14971, and equipment/process validation.
- Experience managing cross-functional/company engineering projects.
- Strong drive and communication skills.
- Professional proficiency in English
- A key role in shaping Vivostat’s future manufacturing technologies and product platforms.
- Broad responsibility across manufacturing development, equipment implementation, and product engineering.
- A collaborative and entrepreneurial environment with short decision-making paths.
- Significant influence on technical decisions and project direction.
- Close interaction with international partners and suppliers.
- Competitive compensation package including pension and health insurance.
About Vivostat
Vivostat develops, manufactures, and markets innovative medical device solutions that transform a patient’s own blood into fibrin- and platelet-rich biomaterials for use in regenerative surgery. Our products are used by healthcare professionals worldwide across a range of surgical specialties, helping to improve healing and patient outcomes.
Joining Vivostat means becoming part of a small dedicated team that combines innovation, quality, and practical execution to improve patient care globally.
For more information, visit www.vivostat.com.
Application
Please submit your application via ”Apply”. Interviews will be held on a rolling basis, and we reserve the right to close the vacancy once a suitable candidate has been identified.
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