Job Details

JOB SUMMARY

Leads product design and development from concept through commercialization while providing technical and functional leadership to engineering staff. Responsible for driving cross‑functional development activities with Manufacturing, Quality, Regulatory, and BusinessDevelopment, ensuring adherence to design controls, manufacturability, and regulatory requirements while optimizing product performance, cost, and scalability.

JOB DUTIES

• Leads and manages design and development activities from customer requirements through proof of concept, verification/validation, and commercialization.
• Provides technical leadership and direction to engineers and designers, including mentoring, prioritization of work, and performance guidance.
• Owns product development programs, including timelines, deliverables, and cross‑functional alignment with Manufacturing, QA/RA, Supply Chain, and Business Development.
• Ensures compliance with design control requirements, including development and maintenance of Design History Files (DHF) and Technical Files. Reviews and approves engineering designs, drawings, specifications, and test protocols to ensure accuracy, completeness, and adherence to standards.
• Drives Design for Manufacturability, Inspection, and Assembly (DFMIA) to ensure efficient and scalable production processes.
• Evaluates and resolves complex design and process issues that impact product performance, manufacturing, inspection, or assembly.
• Leads tolerance analysis, risk assessments, and design reviews to support robust product development.
• Collaborates with internal teams and external suppliers to support development efforts, troubleshoot issues, and optimize designs. Provides technical support to Management, Manufacturing, Quality, Regulatory, and Purchasing as needed.
• Oversees verification and validation activities, including development of test methods, protocols, and reports. Gathers and analyzes data related to manufacturing processes, costs, materials, and methods to support decision making. Participates in or leads customer interactions related to product development initiatives.
• Ensures adherence to company policies, procedures, and regulatory requirements. Leads or participates in continuous improvement initiatives related to engineering processes and product development.
• Performs other duties as assigned.

SKILLS AND QUALIFICATIONS

• Bachelor's Degree in Mechanical Engineering, Electrical Engineering, or related field required.
• Minimum of 7+ years of relevant industry experience, including product design and development.
• Prior experience in a leadership or supervisory capacity strongly preferred.
• Experience in regulated industries required, preferably medical device, with working knowledge of IEC 60601‑x, ISO 13485, and FDA 21 CFR Part 820.
• Strong experience with design controls and Design History File (DHF) requirements. Experience with Risk Management (ISO 14971) preferred. Proficiency in 3‑D CAD software (SolidWorks preferred).
• Strong background in electromechanical product design and development. Experience with CNC machining and manufacturing processes preferred.
• Strong understanding of Design for Manufacturability, Inspection, and Assembly (DFMIA).
• Advanced knowledge of ASME Y14.5 GD&T and engineering drawing standards. Ability to perform tolerance stack‑up analysis.
• Strong analytical and problem‑solving skills with a data‑driven approach.

ACCOUNTABILITIES

• Provide leadership, direction, and accountability for design and development team performance.
• Own outcomes of product development programs, including quality, timelines, and deliverables.
• Exercise independent judgment and initiative in technical and managerial decision making.
• Ensure compliance with all regulatory, quality, and company standards.
• Promote best practices, continuous improvement, and engineering excellence.
• Maintain a safe working environment.
• Hands‑on leadership approach to problem solving and execution.
• Expected to provide additional effort as needed to meet critical deadlines and business objectives.

EDUCATION AND EXPERIENCE

Bachelor's degree in engineering (mechanical, electrical, or equivalent) 5‑10 years' experience as a Design Engineer within medical device industry. Advanced engineering degree a plus.

MENTAL, PHYSICAL AND VISUAL DEMANDS

While undertaking the essential duties and responsibilities of the position, the employee must repeatedly sit, listen, speak, type and move throughout the facility and must be capable of using a keyboard for computer purposes. This role may require the employee to periodically lift and/or move up to 50 pounds. The employee may be required to conduct inspections under magnification.

EMPLOYMENT EQUAL OPPORTUNITY STATEMENT

We are an Equal Employment Opportunity (“EEO”) Employer.

We are an equal opportunity employer that is committed to diversity and inclusion in the workplace. We prohibit discrimination and harassment of any kind based on race, color, sex, religion, sexual orientation, national origin, disability, genetic information, pregnancy, or any other protected characteristic as outlined by federal, state, or local laws.

This policy applies to all employment practices within our organization, including hiring, recruiting, promotion, termination, layoff, recall, leave of absence, compensation, benefits, training, and apprenticeship. The Company makes hiring decisions based solely on qualifications, merit, and business needs at the time