Senior Product Development Engineer--Medical Device

Senior Product Development Engineer—Medical Device

One of the Pacific Northwest's fastest growing Medical Device companies seeks an experienced Product Development Engineer to join their talented and highly collaborative Development Team. Qualified candidates should have at least 5 years of experience developing Medical Devices and have a firm understanding of the Design Control Process. Excellent benefits and a fantastic culture.

Development Engineer III will develop systems, processes, methodologies as well as product development to enhance our product offering. Transforming concepts into prototypes for testing, validation, and improvement for production.

• Thrives in an environment where technical learning is hands on.
• A desire to be creative, improve processes and find solutions for the next generation of medical devices.
• Is detailed oriented to plan, execute, and document their work through reports and data analysis.
• Enjoys a team model where all individuals are encouraged for personal growth.
• Is excited at the opportunity to be a technical project leader interacting with our customers.

• Plan, conduct, and manage design and development projects for medical devices in support of the company's strategic plan.
• Lead the development of new patient specific products.
• Maintain productive and respectful dialogue with customers to determine product requirements and ensure customer needs are met.
• Determine project schedule and strategy by studying project plan, specifications, calculating and risks, calculating time requirements, and sequencing project elements.
• Complete technical studies and prepare cost estimates.
• Manage compliance, quality control, and quality assurance standards and specifications.
• Mentor, lead and support other members of the engineering staff.
• Engage outside contracting services in support of project needs, i.e., analytical laboratories, consultants, material suppliers and equipment suppliers. Build effective relationships with these resources to meet delivery and budgetary goals.
• Research and understand device functionality, device patents, and clinical use.
• Design and develop products in full compliance with the internal Medical Design Control requirements per SOP
  820.030, and maintain design files for company products, including testing, testing reports, verification, validation, design files, and design reviews.
• Communicate with senior management to remove barriers/obstacles that could impair the projects timeline and/or overall success. Escalate barriers/obstacles to the appropriate leader to keep the project on track, on time, and within budget. Control costs by approving expenditure and seeking authorizations from the upper management as needed.
• Support all Company initiatives as identified by management and in support of Quality Management Systems (QMS), Environmental Management Systems (EMS), and other regulatory requirements.

• Bachelor’s degree in Mechanical, Materials Science, Chemical, Electrical or Biomedical engineering or equivalent work experience.
• 4-10 years of experience working with medical devices; development, reprocessing and/or manufacturing.
• Experience with FDA 510(k) process or other regulatory submissions preferred.
• Experience in a LEAN Manufacturing/Production environment, GMP and/or New Product Development preferred.

• Medical insurance
• Vision insurance
• 401(k)
• Tuition assistance
• Disability insurance