SUMMARY

• The Product Design Engineer is responsible for developing new and sustaining existing medical devices and accessories. This includes product design, supporting manufacturing planning and launch, maintaining engineering documents (BOMs, drawings, specifications, manufacturing procedures), and implementing design improvements and modifications after product launch. This role is a liaison between research & development, product design, and manufacturing.

PRIMARY RESPONSIBILITIES

• Lead or contribute to product design input requirements, specifications, generating design concepts, prototype builds, pre-clinical evaluations, and transferring to manufacturing.
• Lead or contribute to the creation and maintenance of Design History Files (DHF).
• Perform analysis and establish test plans to demonstrate products meet all requirements.
• Provide project management in development of new products.
• Identify and qualify vendors and outsourcing partners.
• Contribute to project team activities as assigned.
• Lead design and development of new products, product changes, and enhancements.
• Partner with Product Development staff to ensure that products under development are designed for manufacture.
• Generate and maintain BOMs, inspection plans, labeling, and other product documents.
• Support product development efforts by creating CAD models and drawings using SolidWorks and/or creating electrical schematics.
• Conduct product flow evaluations and implement process improvements to maximize efficiencies in new and established manufacturing processes.
• Transfer new products and product changes to production (pilot and full-scale). Prepare estimates of time and cost for production qualification and production transfer projects.
• Lead prototype and pilot production of new products, product changes, and enhancements.
• Plan and execute manufacturing process validation activities.
• Author and lead team review of Process Failure Modes & Effects Analyses (PFMEAs), Failure Modes & Effects Analyses (FME), and Fault Tree Analyses (FTA).
• Utilize costed BOMs, timed pilot builds and scheduling to establish cost of goods sold (COGS). Identify initiatives to reduce or contain cost, improve material flow, evaluate capacity and other continuous improvements.
• Work toward resolution of manufacturing issues (NCMR and CAPA support).
• Assist with day to day operations including vendor identification, quoting, purchasing, receiving, inventory management, and supplier management.
• Provide engineering and technical support to operations, engineering and quality teams.

KNOWLEDGE AND SKILL REQUIREMENTS

Experience, Competencies, Education:

• A Bachelor's degree in biomedical, mechanical, electrical, manufacturing or a related engineering field is required.
• The ideal candidate has a minimum of three years of experience in design/manufacturing/sustaining engineering, preferably in the medical device industry.
• Experience in medical device development, design transfer, design for manufacturability (DFM), reliability and cost.
• Understanding of medical device DHF, DMR, and DHR files management and documentation requirements.
• Experience in component design, manufacturing, materials and testing of equipment is required.
• Validation experience in developing and executing IQ, OQ and PQ process validation activities.
• Familiar with manufacturing processes typical of electronic medical equipment, including formed, machined and molded parts, and automated SMT processes.
• Proficiency in using statistical methods.
• Must be organized and must be able to work on multiple projects with a minimum of supervision and meet established timelines.
• Excellent organizational, interpersonal, oral and written communications skills.
• Proficiency in MS Word, Excel, Visio, MS Project, PowerPoint, SolidWorks.

WORKING CONDITIONS

• Ability to “get the job done” in a we-can-do environment, allowing for flexible hours, depending upon the project and/or customer needs
• Small office environment (does own documentation and interacts directly with others in virtually all situations)
• Small laboratory / shop environment (performing actions directly or with the aid of a technician)
• Travel will be minimal, and when necessary, can usually be well planned in advance (examples include industry trade meetings, technical training, visits to key user sites, etc.)