Staff Engineer, Hardware, Mechanical R&D - Medical Device

Job Summary:

At Werfen, we believe in making a difference in people's lives. As a Staff Engineer, Hardware, you will have the opportunity to contribute to the development of innovative medical devices that directly impact patient outcomes.

You will be part of an enthusiastic team of talented individuals who share the goal of improving healthcare. Werfen focuses on providing a supportive and inclusive work environment where ideas are valued, and professional growth is prioritized. You will have the chance to leverage your hardware expertise to drive meaningful advancements in the medical field.

• Provide technical leadership to project teams.
• Assist with vendor selection for parts and tools.
• Provide recommendations for new product development.
• Plan work according to general program schedule and adhere to milestones.
• Complete assignments on time and within budgetary limitations.
• Prepare technical reports and documentation.
• Leverage expertise to create robust designs.

• Eight (8) years previous relevant industry experience required, preferably within a regulated medical device or pharmaceutical environment.
• Bachelor’s degree or higher in Mechanical Engineering preferred.

• Stay up to date with industry trends, emerging technologies, and advancements in medical device hardware to drive innovation within the company.
• Ensure compliance with medical device regulations and standards and assist with product validation and verification processes.
• Ensure designs are optimized for manufacturability (DFM).
• Evaluate and select appropriate components and technologies, considering both performance and manufacturing requirements.
• Troubleshoot hardware issues, identify root causes, and implement effective solutions to optimize device performance.
• Expert in plastic mold design, utilizing plastic mold flow analysis to optimize designs.
• Lead the end-to-end hardware development lifecycle, including prototyping, testing, and manufacturing.
• Solidworks Data Management experience is required.
• Experience with the following tools/methods: FEA, Six Sigma, DOE, FMEA, Minitab, Arduino, Word, Power Point, Excel is highly desired.
• Work cross-functionally with R&D, Manufacturing, and Quality teams to develop and improve processes for new and existing medical device products.

Less than 10% of time