Senior Product Development Engineer

Kuros Biosciences

. Lead cross-functional Project Teams through all phases of Design and Development .

Posted 11/6/2026full-timeBilthoven • NetherlandsSenior💰 €6,500 - €7,000 per monthWebsite

Core Competencies

Role fit

Core Competencies

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Demonstrates expertise in biomaterials development, regulatory compliance, and project management within the medical device industry. Proficient in leading cross-functional teams and ensuring adherence to ISO standards throughout the design and development process.

Highest-signal resume keywords

Biomaterials DevelopmentDesign ControlRegulatory SubmissionsProject LeadershipISO 13485 Compliance

ATS Keywords

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Applicant Tracking System Keywords

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Hard Skills

Biomaterials Formulation DevelopmentExperimental DesignData AnalysisVerification and Validation StrategiesDesign TransferManufacturing ProcessesDesign History File (DHF) OwnershipRisk ManagementDocumentation PreparationTechnical Report Writing

Soft Skills

Strong CommunicationInterpersonal SkillsProblem-SolvingCritical ThinkingTeam Collaboration

Industry Keywords

Medical Device DevelopmentCombination ProductsISO 14971Quality SystemsSafety Standards

About the role

Key responsibilities & impact

Lead cross-functional Project Teams through all phases of Design and Development
Conduct multiple experiments and translate results into regulatory compliance
Coordinate and report technical deliverables throughout Design and Development phases
Own and maintain Design History Files (DHF) in compliance with regulatory and internal requirements
Define design inputs and outputs and ensure traceability throughout development
Drive verification and validation activities, including protocol development and execution
Lead design transfer to manufacturing, ensuring scalability and robustness
Identify and coordinate vendors, including materials suppliers and contract manufacturers
Create and manage project timelines, milestones, budgets, and deliverables
Coordinate internal and external stakeholders, including vendors, CROs, and CDMOs
Stay current with bone replacement-material technologies and share knowledge across teams
Manage and support team members and foster collaboration
Collaborate with Research, Quality, Regulatory, Commercial, and Manufacturing teams
Identify risks and implement mitigation strategies
Contribute to patents, technical reports, publications, internal decision-making data, and external communications
Ensure compliance with design control processes, ISO 13485, and applicable regulatory requirements
Contribute to ISO 14971 risk-management activities
Prepare and review regulatory-submission documentation, SOPs, test methods, and development procedures
Ensure development work is documented and inspection-ready
Adhere to safety standards and participate in evaluating new procedures, supplies, and equipment
Train colleagues and students
Use equipment, disposables, and time responsibly and cost-effectively

Requirements

What you’ll need

MSc in (bio)material science, biomedical engineering, Chemistry or related field
5+ years of experience in medical device or combination product development
Demonstrated experience in project and team leadership
Strong background in biomaterials development (bone grafts, ceramics, polymers preferred)
Experience with design control and DHF ownership
Experience working with external partners and vendors
Expertise in biomaterials formulation development and characterization, experimental design and data analysis
Expertise in verification and validation strategies, design transfer and manufacturing processes
Knowledge and application of Design and Development Procedures
Knowledge of ISO 13485 quality systems and ISO 14971 risk management
Experience preparing and reviewing documentation supporting regulatory submissions, such as 510(k) and technical files
Ability to work independently and cooperatively in a professional team
Strong communication, interpersonal, problem-solving, and critical-thinking skills
Ability to translate scientific concepts into practical product solutions
Ability to adhere to safety standards concerning emergency preparedness, chemical, infectious-agent, and radioactive hazards

Benefits

Comp & perks

Competitive salary
Opportunities for career growth
Positive and collaborative work environment
International, innovative company with a diverse and energetic team