We are seeking a highly skilled and experienced Senior Product Development Engineer with a focus on Electro-Mechanical Verification and Validation (V&V) to join an innovative team at a leading medical device company.
The ideal candidate will play a critical role in ensuring the reliability and performance of our cutting-edge electro-mechanical medical devices through rigorous verification and validation processes.
This role involves collaborating with cross-functional teams, including R&D, Quality Assurance, Regulatory Affairs, and Manufacturing, to bring new products from concept to market.
Collaborates as a key member of the R&D, Systems and V&V teams to ensure that product requirements are relevant, testable and measurable.
Defines, plans and leads activities, including, test method & measurement system development and validation, fixture design and testing optimization in support of Design Verification or Design Validation.
Authors and executes Design Verification plans or protocols to ensure design input requirements are satisfied to all relevant Quality System and regulatory requirements.
Defines and leads the execution of a suitable product reliability test plan to critically evaluate system performance and reliability, ensuring that the product is adequately pressure-tested to satisfy user, regulatory and business requirements.
Leads the execution of IEC 60601 mechanical safety testing relevant to the product profile, working with external lab vendors to ensure appropriate product certifications.
Ensures Design Verification testing is performed with sample sizes that meet the requisite confidence level and reliability, proportional to the risk assessed for the relevant design inputs.
Authors Design Verification test reports to support regulatory submissions for new products, derivative products or regulatory approvals to expanded geographical regions.
Implements DFSS rigor throughout the design selection and development process, leveraging and deploying empirical, statistical and analytical tools which will improve design decisions and reduce design iteration cycle times.
Synthesizes, develops, updates and optimizes designs that meet requirements by understanding design space with design options and tradeoffs, managing critical parameters, leverages strong engineering fundamentals and tools and integrating manufacturing principles early in the development.
Requirements:
Bachelor's degree in mechanical engineering, Electrical Engineering, Systems Engineering, Biomedical Engineering or related field.
10+ years of professional experience leading or supporting product development projects, including electrical and mechanical systems.
5+ years of experience with leading or executing Design Verification of disposable electromechanical medical devices.
Proven track record of leading successful V&V projects for electro-mechanical devices from concept to market.
Strong knowledge of medical device regulations and standards (e.g., FDA, ISO 13485).
Proficiency in CAD software (e.g., SolidWorks) and other engineering tools.
Excellent problem-solving skills and attention to detail.
Strong communication and interpersonal skills.
Ability to work effectively in a team-oriented, collaborative environment.
Experience as lead in the development of medical disposable devices highly desired.
Experience with software or firmware development compliant with IEC 62304 highly desired.
Six Sigma certification training / experience.
Pharmaceutical Infusion pump development experience.
Expertise in common risk management techniques highly desired.
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