Bachelor's degree in Mechanical/Biomedical Engineering or Materials Science; advanced degree preferred.
6+ years of experience in medical device development or 4+ years with advanced degree.
Strong experience with design controls in medical device environments.
Proven ability to lead technical workstreams and cross-functional teams.
Knowledge of risk management, V&V, traceability, and change control processes.
Experience with PLM systems like Windchill is preferred.
Self-starter with strong accountability and adaptability.
Responsibilities
Lead integration workstreams for technical execution and interface definitions.
Drive technical decision-making with engineering leadership.
Ensure completion of design control deliverables and user needs alignment.
Support risk management documentation and mitigation activities.
Oversee verification & validation (V&V) planning and execution.
Develop and maintain DHF in compliance with regulations.
Conduct feasibility studies and iterative testing for design optimization.
Benefits
Collaborative work environment with cross-functional partners.
Opportunity to influence and drive integration strategies.
Engagement with advanced technologies in medical device development.
Professional growth in a fast-evolving industry.
Full Job Description
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.
This position plays a key role in shaping integration strategy and ensuring successful execution of downstream deliverables in a highly collaborative environment.
Roles & Responsibilities:
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.
Requirements:
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.
