About Cardiovascular
Fueled by innovation at the intersection of biology and technology, we're developing the next generation of smarter, less invasive, more personalized treatments. Our Cardiovascular team develops leading solutions for heart recovery, electrophysiology, and stroke, continually elevating standards of care for stroke, heart failure and atrial fibrillation (AFib) patients.
Position Overview
The Manager, NPI Engineering provides leadership, technical support, and effectively manages and develops direct reports. Responsible for product and process development, resources, and project management activities associated with executing the company's goals and objectives.
Essential Job Functions
•Manage, lead, and mentor engineer(s) and/or technician(s).
•Lead all cross-functional project activities from concept through clinical trial and commercial release of product.
•Mentor and support a variety of development and engineering activities, which mainly focus on catheter design and development.
•Design and develop products and processes in full compliance with the company's Design Control requirements and consistent with FDA, ISO and MDD requirements.
•Coordinate technical personnel and their activities involved in developing new and improved products and manufacturing processes.
•Ensure that development activities are properly documented through lab notebook, history file, Engineering Reports and other records.
•Coordinate cross-functional alignment and support for program success.
•Manage outside vendors and contractors providing products or services.
•Create, maintain, and communicate project timelines for internal and outside development projects.
•Provide regular updates of key milestones and issues to the project team as well as management.
•Identify issues and recommend solutions for products in development.
•Contribute ideas to new product development, as defined by product specification, process development, and manufacturing technologies.
•Approve test methods, acceptance criteria, and test equipment for all stages of product development.
•Review and approve documents as specified in Document Control SOP.
•Compile the Design History File and conduct design reviews in compliance with Design control procedures.
•Ensure that products have capable manufacturing processes and that process verifications and validations are completed.
•Interact with cross-functional groups to ensure that products and processes are compatible with other products and processes in the intended operating system, and have met all requirements per design control process.
•Other duties as assigned.
•Provide technical leadership for projects, including managing process and technology development teams.
•Maintain up-to-date knowledge of competitive technologies and biomedical developments relevant to the company's products.
•Ensures that products and processes satisfy acceptable quality standards and customer needs with consensus from cross-functional groups.
•Support company goals, policies, procedures, quality systems, and compliance with FDA and other regulatory bodies.
Requirements
•B.S. in Engineering or equivalent work experience.
•Minimum of 10 years' progressive experience in medical device development, including 3+ years' experience in leading projects in all phases of product development.
•2+ years managing direct reports or equivalent experience.
•Knowledge of QSR and applicable Quality System Standards.
•Experience with disposable medical device development preferably coronary and/or vascular catheters.
•Strong understanding of engineering materials, component selection, and design for safety, reliability and manufacturability.
•Solid communication and presentation skills with level of comfort being the spokesperson and leader of a team.
•Experience taking a product from concept through clinical or commercial release.
•Ability to work in a fast-paced environment while managing multiple priorities.
•Operate as a team and/or independently while demonstrating flexibility to changing requirements.
•Employee may be required to lift objects up to 25lbs.
Additional Information
•The Company maintains highly competitive, performance-based compensation programs. This position is eligible for an annual performance bonus in accordance with the terms of the applicable plan, awarded at the Company's discretion on an individual and corporate performance basis.
•Employees and/or eligible dependents may be eligible to participate in Company sponsored employee benefit programs: medical, dental, vision, life insurance, short- and long-term disability, business accident insurance, and group legal insurance.
•Employees may be eligible to participate in the Company's consolidated retirement plan (pension) and savings plan (401(k)).
•Time off benefits: Vacation – up to 120 hours per calendar year; Sick time – up to 40 hours per calendar year (up to 56 hours for employees residing in Washington State); Holiday pay, including Floating Holidays – up to 13 days per calendar year; Work, Personal and Family Time – up to 40 hours per calendar year.
Preferred Skills
Agile Decision Making, Benchmarking, Crisis Management, Developing Others, Disruptive Innovations, Emerging Technologies, Inclusive Leadership, Leadership, Lean Supply Chain Management, Process Control, Process Engineering, Process Improvements, Product Costing, Program Management, Project Schedule, Science, Technology, Engineering, and Math (STEM) Application, Team Management, Technical Research, Technical Support
Pay
The anticipated base pay range for this Bay Area position is $121,000.00 - $209,300.00.
