Sr Product Engineer

Sr. Product Engineer

Comp: $110-140K

POSITION SUMMARY:

Lead and manage the successful specification, design and manufacture of assigned product(s). Define product specifications to meet user requirements, define and implement test methods to verify products performance to meet specifications. Direct the contract manufacture of production including production planning. Conduct reviews and analysis of field product problems and develop corrective actions to product design, specifications and/or manufacturing processes as needed. Support the field sales team with technical direction on product performance. Ability to work as a part of a team or independently with minimal supervision.

PRIMARY (Essential) FUNCTIONS:

1) Serve as a technical expert to define and modify product specifications and design/manufacturing documents to enhance or improve products:

• Create or modify product specifications to improve product performance based on field data.
• Modify design/manufacturing documents (i.e. work instructions, BOMs) to enhance manufacturing processes.
• Create or gather product relevant documents to support quality and regulatory functions (i.e. design documents needed for audit or regulatory submissions).

2) Define and lead new product design & development activities of assigned product(s) including necessary planning to meet desired objectives:

• Develop project plans, product specifications, design documents & design reviews for assigned product(s).
• Design 3D CAD models of component parts, assemblies & BOM’s for the assigned product(s).
• Build, evaluate and analyze prototypes as needed for feasibility & proof of concept testing to ensure desired performance is obtained.
• Provide support for contract manufacturing partners to meet production objectives by resolving component reliability issues, participating in return investigations, and secondary supplier issues.

3) Lead sustaining engineering efforts on assigned products:

• Initiate and implement design / process changes as needed to maintain the continuous production of assigned products in the event of obsolescence issues.
• Perform and/or recommend appropriate engineering analyses regarding product system performance, assembly methods / processes, components and sub-assembly designs, as part of sustaining activities and at various project phases in relation to new products or systems.
• Collaborate with other engineering team members to create or support drawing changes and product specifications based on manufacturing or field user feedback
• Communicate with suppliers & contract manufacturers on parts inventory & disposition, design changes, and quality requirements to avoid disruptions in product delivery.
• Visit suppliers as needed to maintain continual support of production operations, evaluate product modifications and develop solutions when manufacturing related issues arise.
• Lead required compliance activities (such as RoHS) as needed by reviewing bill of materials, component specifications and supplier documentation.

4) Conduct and direct laboratory testing & analysis related to product design and development, safety, performance & as well as troubleshooting existing devices. Establish testing protocols, document test results for later analysis. Maintain laboratory, equipment & supplies as needed.

• Generate technical test protocol document(s), perform data analysis and incorporate into written technical reports / presentations.
• Set up and perform laboratory bench test methods and procedures, as needed for troubleshooting.
• Generate test documents for use internally or at third parties, i.e. contract manufacturers.
• Direct and/or carry out laboratory testing for the evaluation of new and existing devices & products. Includes tests related to sustaining activities on existing or modified product systems.
• Ensure devices meet the defined and applicable user requirements and standards.
• Perform complex engineering analyses of component and assemblies using appropriate tools.
• Analyze and review customer complaints vs. repair costs data to identify design issues with high cost drivers and put into the feedback loop for product improvements.

OTHER FUNCTIONS:

• Support in organizing and maintaining design labs & equipment.
• Participate in change requests and document reviews.
• Support cross-functional teams in defining and implementing departmental processes.
• Other duties as assigned.

QUALIFICATIONS:

• Bachelor’s Degree in Engineering or similar discipline (Life Sciences).
• Min 7 years of product development and/or manufacturing experience in medical device industry (Level 2 or 3).
• Experience with product and process quality by designing test methods; testing finished product and process capabilities; establishing standards; confirming manufacturing processes.
• Experience with electrical, electronic and mechanical lab and troubleshooting tools.

SKILLS/ABILITIES:

• Working knowledge of Microsoft products such as Word, Excel, PowerPoint, etc.
• Ability to work with third party suppliers and external manufacturing partners.
• Demonstrated Project Management skills.
• Ability to work with multi-disciplinary teams such as Sales, Marketing, Manufacturing and Quality at both domestic and international locations.
• Self-motivated, good organizational skills and good verbal / written communication required is a must.
• Proficient with SolidWorks CAD is a must.
• Ability to work with electrical, electronic and mechanical lab and troubleshooting tools is a must.