Staff Engineer

Position Summary

The Staff R&D Engineer is a technical leader within the Sustaining Engineering organization, responsible for supporting the global lifecycle management of commercially released medical devices. This role evaluates existing product designs against evolving clinical needs, customer requirements, regulatory expectations, and business objectives, and develops practical, risk-based solutions that ensure product compliance, continuity of supply, global registration expansion, and long-term portfolio success. The position collaborates closely with cross-functional teams across R&D, Quality, Regulatory Affairs, Operations, Manufacturing, and Marketing to drive design improvements, product enhancements, and technical assessments throughout the product lifecycle.

Core Responsibilities

• Lead or serve as the technical lead for sustaining engineering projects supporting global product portfolios.
• Evaluate product designs against evolving clinical, customer, regulatory, and business requirements and identify opportunities for improvement.
• Develop and implement technical solutions that support global product registrations, market expansion, compliance initiatives, and product enhancements.
• Lead technical assessments related to design changes, component obsolescence, supplier changes, manufacturing improvements, and risk mitigation activities.
• Apply design control, human factors, usability, and risk management principles to changes affecting released products.
• Support regulatory submissions, technical files, risk analyses, and design change documentation.
• Leverage post-market surveillance, customer feedback, and clinical insights to drive continuous product improvement.
• Facilitate technical decision-making by balancing customer needs, patient safety, regulatory requirements, business objectives, and implementation feasibility.
• Serve as a technical mentor and subject matter expert within the organization.

Required Qualifications

Education & Experience: Bachelor's degree in Mechanical Engineering, Biomedical Engineering, Systems Engineering, or a related technical discipline with 8+ years of relevant experience; or Medical device industry experience required.

Technical Knowledge: Demonstrated experience supporting commercially released medical devices through lifecycle management, design changes, or sustaining engineering initiatives. Strong knowledge of Design Controls (21 CFR Part 820, ISO 13485) and Risk Management (ISO 14971). Working knowledge of biocompatibility principles (ISO 10993), clinical use considerations, and regulatory requirements impacting product design and market access. Experience supporting global regulatory submissions, product registrations, and technical documentation. Ability to perform complex technical evaluations and develop practical, compliant engineering solutions. Understanding of the interactions between product design, materials, manufacturing processes, patient safety, regulatory requirements, and clinical performance.

Skills: Strong analytical and systems-thinking capabilities. Excellent communication skills with the ability to translate complex technical information across organizational levels. Ability to evaluate technical, regulatory, clinical, and business tradeoffs to make sound recommendations. Proven ability to influence cross-functional teams and drive alignment without direct authority.

Preferred Qualifications

• Master's degree in a related engineering discipline with 6+ years of relevant experience.
• Advanced degree in Mechanical Engineering, Biomedical Engineering, Systems Engineering, or related discipline.
• Experience supporting global registration expansion and international regulatory requirements.
• Experience with design verification and validation, root cause investigations, post-market surveillance, and complaint analysis.
• Knowledge of plastics engineering, fluid mechanics, infusion systems, medical device materials, or high-volume manufacturing.
• Experience with statistical analysis and data analytics tools such as Minitab.
• Demonstrated ability to lead complex cross-functional initiatives and influence technical strategy across multiple products or platforms.

Impact and Scope

This role operates with a high degree of technical independence and is expected to influence product strategy, technical decision-making, and lifecycle management activities across multiple products and geographies. The Staff Engineer identifies opportunities to enhance product performance, support global market access, mitigate risk, and ensure the continued success of the product portfolio through practical, patient-focused, and compliant engineering solutions.