Senior R&D Engineer (Mechanical & DFX Engineering)

Description

The primary focus of this Senior R&D Engineer role is to design and develop medical devices as well as product changes and enhancements for low product cost by applying design for excellence (DFX) and scalable processes. The engineer will generate risk documentation, develop design input requirements and test methods, conduct verification testing, and establish the design history file. This role interfaces with multiple functions including manufacturing, production, supply chain, quality, regulatory, and other engineers.

The ideal candidate is a quality-focused self-starter with high attention to detail who thrives in a small, fast-paced environment. They have strong communication skills, high sense of ownership, and drive for continuous improvement and professional growth. We seek candidates who are passionate about improving healthcare and motivated to do the hard and exciting work required to bring ground-breaking technology to market and expand existing products globally.

Essential duties and responsibilities include, but are not limited to, the following:

• Design and develop new products, product changes, and enhancements with a focus on manufacturability, scalability, and cost-effective solutions.
• Apply design for excellence (DFX) principles including design for manufacturability (DFM), design for assembly (DFA), and design for testability (DFT) to ensure efficient, reliable, and high-quality production.
• Implement scalable and lean manufacturing processes while understanding how mechanical components integrate with electronic and software-controlled systems.
• Build and test preliminary ideas using rapid prototyping tools to evaluate design concepts and iterate toward final solutions.
• Engage in hands-on bench testing, fixture development, and test method validation.
• Work directly with suppliers to design custom components, generate drawings, and ensure manufacturability.
• Develop requirements based on clinical and engineering inputs, applicable standards, and regulatory authority guidance documents.
• Conduct risk management documentation including hazard analysis and failure modes and effects analyses (FMEA/FMECA) to identify and mitigate design and process risks.
• Design and execute verification test protocols, methods, and reports to ensure design outputs meet design inputs.
• Lead root cause analysis investigations for product failures and test anomalies using structured approaches such as 5 Whys, fishbone diagram, design of experiments (DOE), and statistical analysis.
• Assess the impact of proposed product design changes to requirements, risks, and verification to determine appropriate updates to traceability, regression testing, and documentation.
• Support design reviews, risk assessments, and requirements reviews throughout the product development lifecycle from concept through post-market surveillance.
• Author design history file (DHF) deliverables and reports in accordance with internal quality system procedures and external regulations.
• Support design transfer from development through manufacturing, including training and documentation.
• Collaborate with cross-functional teams including manufacturing, production, supply chain, quality, regulatory, and other engineers to mitigate potential production challenges and design limitations.
• Support the resolution of product complaints, non-conformances, and corrective and preventive actions (CAPA).

Other Duties and Responsibilities

• Train and supervise technicians.
• Initiate document change orders (DCO) in the quality management system (QMS).
• Support internal and external audits as required.
• Support company goals and objectives, policies, and procedures.
• Comply with design controls, standards, and regulations.
• Other duties as assigned.

Education and Required Experience

• Minimum BS degree or equivalent in mechanical, biomedical, systems, or related engineering discipline.
• Minimum 5 years of experience in mechanical, manufacturing, process, systems or related field developing commercial medical products.

Knowledge, Skills, and Abilities

• Experience with design for excellence (DFX) principles including design for manufacturing (DFM), design for assembly (DFA), and design for testability (DFT).
• Experience implementing scalable and lean manufacturing processes.
• Experience performing hands-on bench testing, fixture development, material selection, and test method validation.
• Experience with medical device product development lifecycle and design controls per ISO 13485 and FDA 21 CFR 820.
• Experience performing risk management activities and hazard analysis per ISO 14