R&D Engineer
Katalyst Healthcares and Life Sciences
Job Summary:
- The role involves leading integration workstreams, supporting design and quality system integration activities, and collaborating closely with engineering leadership, technical teams, quality, manufacturing, supplier engineering, and regulatory stakeholders.
- This position plays a key role in shaping integration strategy and ensuring successful execution of downstream deliverables in a highly collaborative environment.
- Lead integration workstreams including interface definition, requirements alignment, planning, and technical execution.
- Drive technical decision-making across assigned deliverables in collaboration with engineering leadership.
- Own and ensure completion of design control deliverables including user needs, design inputs/outputs, and traceability.
- Support risk management documentation and mitigation strategy activities.
- Lead verification & validation (V&V) planning and execution activities.
- Support DHF development and maintenance in compliance with regulatory standards.
- Lead or oversee test method development and validation activities to ensure integration readiness.
- Conduct feasibility studies, prototype development, and iterative testing activities to optimize designs across device platforms.
- Perform root cause analysis, resolve complex technical issues, and proactively identify and mitigate integration risks.
- Partner cross-functionally with quality, manufacturing, supplier engineering, and regulatory teams to drive execution and alignment.
- Influence cross-functional stakeholders and provide technical leadership without direct line management responsibility.
- Collaborate closely with engineering managers, technical leads, engineers, and lab/testing support teams in a highly collaborative environment.
- Bachelor's degree in Mechanical Engineering, Biomedical Engineering, Materials Science, or related field. Advanced degree preferred.
- 6+ years of industry experience or 4+ years with an advanced degree.
- Strong experience in medical device development within a design controls environment.
- Experience with catheter-based and/or single-use medical devices.
- Proven ability to lead technical workstreams and influence cross-functional teams.
- Strong working knowledge of design controls, DHF documentation, risk management, V&V, traceability, and change control.
- bility to work independently with minimal guidance.
- Strong problem-solving, communication, and stakeholder management skills.
- Experience with Windchill or similar PLM/quality systems preferred.
- Experience with DMR deliverables including prints, specification maps, and BOM creation preferred.
- Experience with test method development and validation preferred.
- Background in balloon catheter or catheter-based systems preferred.
- Familiarity with Class II/III medical device regulations and quality systems preferred.
- Experience with product or technology integration activities preferred.
- Self-starter with strong accountability, adaptability, and ability to operate in ambiguity.
Vacancy posted 4 days ago
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