Associate Director, Product Development Engineering
- Lead and mentor a team of product development engineers, fostering a culture of innovation, collaboration, and continuous improvement.
- Oversee the entire product development lifecycle for assigned medical devices, including conceptualization, design, prototyping, testing, verification, validation, and transfer to manufacturing.
- Collaborate closely with cross-functional teams including Marketing, Regulatory Affairs, Quality Assurance, Manufacturing, and Clinical Affairs to define product requirements and ensure successful project execution.
- Develop and manage project plans, budgets, and timelines, ensuring projects are delivered on schedule and within budget while meeting all performance specifications.
- Drive the application of design controls, ensuring all relevant design documentation is complete, accurate, and traceable.
- Evaluate and implement new technologies, materials, and processes to enhance product performance, reliability, and cost-effectiveness.
- Conduct design reviews, risk assessments, and failure mode and effects analyses (FMEA) to identify and mitigate potential design flaws.
- Support intellectual property strategies, including patent applications and analysis of competitive landscapes.
- Act as a technical expert and key contributor to strategic planning initiatives for product portfolio development.
- Ensure adherence to all company policies, procedures, and ethical standards.
- Bachelor's degree in Biomedical Engineering, Software Engineering, Electrical Engineering, or a related engineering field is required.
- Minimum of 8-10 years of progressive experience in New Product Development, with at least 3-5 years in a leadership or management role.
- Demonstrated expertise in the full product development lifecycle and launched products (software, firmware, controllers etc.) in a complex matrix-based organization interfacing with multiple stake holders across businesses.
- Experience Bringing Products to Market
- Strong understanding and practical experience with design controls, risk management, and verification/validation activities.
- Proven ability to lead, motivate, and develop high-performing engineering teams.
- Excellent project management skills, including experience with project planning, budgeting, and resource allocation.
- Exceptional written and verbal communication skills, with the ability to effectively present complex technical information to diverse audiences.
- Strong analytical and problem-solving abilities, with a keen attention to detail.
- Ability to work effectively in a fast-paced, dynamic environment and manage multiple priorities simultaneously.
- Experience with cloud connectivity platforms, data analytics and software integration is a plus.
- Masters Degree preferred
- Experience with cloud connectivity platforms, data analytics and software integration is a plus.
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