Development Engineering

Job-ID32367607Reference26-00841 Job Description: 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. Lead integration workstreams including interface definition, requirements alignment, planning, and technical execution. Drive technical decision-making across assigned deliverables in collaboration with engineering leadership. Support risk management documentation and mitigation strategy 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. Collaborate closely with engineering managers, technical leads, engineers, and lab/testing support teams in a highly collaborative environment. Requirements: Bachelor's degree in Mechanical Engineering, Biomedical Engineering, Materials Science, or related field. Strong experience in medical device development within a design controls environment. Experience with catheter-based and/or single-use medical devices. Strong working knowledge of design controls, DHF documentation, risk management, V&V, traceability, and change control. Experience with Windchill or similar PLM/quality systems preferred. Experience with test method development and validation preferred. Familiarity with Class II/III medical device regulations and quality systems preferred.