Process Development Engineer
Process Development Engineer
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1 Vacancy
Job Description
Process Development Engineer
Kuros Biosciences is a Swiss-listed life science company with offices inBilthoven (The Netherlands) Atlanta (USA) and Schlieren (Switzerland). Kuros focuses on the development and marketing of orthobiologics for spinal fusion surgery a procedure used to stabilize the spine in patients with back problems. The Kuros bone repair products are manufactured in Bilthoven and sold worldwide. The Kuros Bilthoven Production Team is looking for a new team member that fits the spirit of an innovative company aiming to become the global leader in orthobiologics. This position will report to the Bilthoven office.
Position Overview
As a Process Development Engineer you will be responsible for designing developing and optimizing manufacturing processes for medical devices ensuring compliance with quality and regulatory standards such as ISO 13485. You will play a critical role in scaling up new products processes and equipment from concept to full production improving process efficiency and ensuring consistent product quality.
- Develop validate and implement robust manufacturing processes for existing and new products
- Collaborate with R&D Quality and Manufacturing teams during product development and transfer to production
- Design process layouts work instructions test protocols and validation documentation (IQ/OQ/PQ)
- Perform process capability studies and root cause analysis for process failures or deviations
- Lead or participate in continuous improvement initiatives (Lean Six Sigma Kaizen etc.)
- Select specify and qualify production equipment tooling and automation systems
- Ensure compliance with GMP ISO 13485 and other relevant standards and regulations
- Support regulatory submissions with process validation data and technical justifications
- Provide technical support for troubleshooting and resolving manufacturing issues
- Maintain clear and accurate documentation and reports
Skills
The successful candidate will be:
- Able to work well independently as well as being able to work cooperatively in a team of professionals and cross functionally
- Excellent interpersonal and people leadership skills
- Good knowledge of English language required
- Excellent communication skills to collaborate with cross-functional team internal and external parties present findings and document processes
- Strong Analytical skills and problem solving skills
- Effective project planning execution and tracking to meet deadlines and budgets
- Continuous improvement experience and project management skills. Ability to design and improve manufacturing processes.
- The ability to think creatively and come up with innovative solutions
- Collaborating effectively with colleagues including operators technicians and other engineers
- Comfortable working in a fast-paced regulated environment
Education and/ or Experience
- HBO (Bachelor) / University (MSc.)in the field of Business Engineering / HLO
- 25 years of experience in process development or manufacturing engineering preferably in the medical device or pharmaceutical industry.
- Experience with IQ/OQ/PQ protocols and process validation.
- Previous experience with working in a GMP environment and/or ISO 13485 is preferred
What We Offer
- A dynamic role with room for growth and impact
- Opportunities to innovate and shape processes
- A supportive collaborative work environment
- Professional development and learning opportunities
Our credentials:
With locations in the United States Switzerland and the Netherlands the company is listed on the SIX Swiss Exchange. The companys first commercial product MagnetOsTM is a unique advanced bone graft that has already been used across four continents. For more information on the company its products and pipeline visit.
- Listing on theSIX Swiss Exchangeunder the symbol KURN
- A commercial & research footprint that spans>20 markets
- 4 teams of internationally renownedclinical and scientific expert advisers
- >25orthobiologics-relatedpatents
- >400 patients evaluatedin Level I randomized controlled clinical trials
- >20well-controlledLevel I-III clinical trials initiated including 6 that are complete
- Level I evidence published inSpine
Kuros Biosciences is an equal opportunity employer that is committed to diversity and inclusion in the workplace. We prohibit discrimination and harassment of any kind based on race color sex religion sexual orientation national origin disability genetic information pregnancy or any other protected characteristic as outlined by federal state or local complies with GDPR and the California Consumer Privacy Act (CCPA).View our CCPA Noticehere.
Required Experience:
Manager
Employment Type
Full-Time
