Lead Mechanical Engineer

We are seeking a self-motivated Mechanical Engineer to support design-related updates across an installed base of ultrasound transducers. This role focuses on implementing mechanical design changes product improvements and documentation updates for a diverse portfolio of released products within a highly regulated environment. You will work closely with a cross-functional engineering team to deliver robust manufacturable and compliant design solutions.

At our State College site teams design manufacture and service diagnostic medical ultrasound transducers (probes) used across a wide range of clinical applications including surgery urology cardiology and radiology. As a high-mix low-volume regulated manufacturing environment the site combines advanced engineering precision manufacturing and lifecycle support to deliver critical imaging technology that enables clinicians to make real-time decisions in patient care.

• Support mechanical design updates across an existing portfolio of ultrasound transducers

• Translate inputs from manufacturing quality and field teams into actionable design solutions

• Design and document new components as well as modifications to existing parts

• Develop mechanical solutions for transducer housings cables accessories and related subsystems

• Create and manage engineering changes (ECOs) drawings specifications and work instructions

• Maintain accurate documentation and configuration control within PLM/PDM systems

• Apply Design for Manufacturability (DFM) and Design for Assembly (DFA) principles

• Support design verification and validation (V&V) activities

• Participate in design-related risk management processes (e.g. DFMEA)

• Ensure compliance with FDA regulations ISO 13485 and internal quality standards

• Collaborate across engineering disciplines and communicate technical updates to stakeholders

• Bachelors degree in Mechanical Engineering or related field preferred or Associate degree with equivalent experience

• 3 years of mechanical design experience in medical devices or a regulated industry preferred

• Proficiency in 3D CAD Modeling (SolidWorks preferred; Creo acceptable)

• Experience with GD&T tolerance analysis and mechanical materials

• Familiarity with measurement tools (CMM calipers micrometers)

• Experience supporting released or legacy products preferred

• Strong knowledge of DFM processes (machining injection molding additive manufacturing)

• Experience with PLM/PDM systems (e.g. Agile SolidWorks PDM MyWorkshop)

• Understanding of FDA and ISO 13485 environments preferred

• Strong problem-solving organizational and documentation skills

• Work on a diverse portfolio of advanced medical devices

• Collaborate in a highly cross-functional engineering environment

• Contribute directly to the quality and performance of products in clinical use

• Be part of a team focused on continuous improvement and engineering excellence

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