Here we GROW again:
Pro-Dex is a provider of Contract Manufacturing and Engineering Services, as well as our own technology and products, to the Medical Device Industry. For over 25 years we have helped both large and small companies design and develop as well as manufacture their products. We have manufactured over 50,000 surgical handpieces over the years and have developed processes and know how to make quality and robust products that withstand the rigors of the operating room. In the last nine years we have also been making our own surgical devices with our patented Adaptive Torgue Limiting technology which improves the surgical process for both surgeons and patients.
We offer competitive compensation packages including benefits such as health insurance, retirement plans, and paid time off. If you are a visionary leader with a passion for driving innovation in engineering, we would love to hear from you. Apply now to join our dynamic team as the Director of Engineering!
Job Summary:
We are seeking a highly skilled and experienced Director of Engineering to lead our engineering department. The ideal candidate ensures all engineering projects, initiatives, and processes are in conformance with organization's established policies and objectives. Requires a bachelor's degree in engineering and 10 years of experience in the medical device field. Demonstrates expertise in a variety of the field's concepts, practices, and procedures. Relies on extensive experience and judgment to plan and accomplish goals.
Duties:
· Manage the Design Control process in full compliance with Medical Device standards.
· Develop and manage technology roadmaps to enable growth and innovation.
· Apply principles of mechanical, electrical, software/hardware and other systems engineering to achieve company roadmap on schedule
· Manage and direct Engineering staff in the development of high‐performance, high‐quality product designs.
· Meet or beat scheduled completion dates for all design (or re‐design) projects.
· Prioritize projects to meet objectives set by CEO and company strategy.
· Ensure that products are designed in a way that they can be produced cost‐effectively.
· Serve as Technical coach – wisdom, experience, perspective.
· Responsible for IP and Patent management.
· Build and maintain cross functional patnerships with Engineering, Operations, Quality, PMO Business Development, Finance, Regulatory and Human Resources
· Develop a robust talent development strategy and succession plan
· Acquire or implement the best Engineering tools – Design concepts, Tolerance Analysis, modular designs for other uses, (FMEA) Failure Mode Effects Analysis, (FEA) Finite Element Analysis.
· Employ safety by design, ergonomic/human factors and design for manufacturing principles in the design process. Ensure completion of projects on schedule and on budget.
· Include crossfunctional feedback from Operations and QA/RA in projects
· Ensures all drawings are reviewed for accuracy.
· Carries out supervisory responsibilities in accordance with the organization’s policies and applicable laws.
· Responsibilities include interviewing, hiring, and training employees; planning, assigning, and directing work; appraising performance; rewarding and disciplining employees; addressing complaints and resolving problems.
· Ensure product quality. Support the timely resolution of all product liability issues. Comply with State and Federal regulations. Minimize legal exposure and/or liabilities of the corporations.
· Reviewing project requirements, RFP’s and proposals.
· Assist with Pro-Dex Sales efforts through customer meetings and proposal support.
· Technical spokesperson for the company.
· Must be familiar with Medical Electrical Safety Standards such as IEC60601, Usability/Human Factors and Safety by Design concepts
· Competent in DOE methodologies
· Good understanding of Risk Management, including FTA, PFMEA, Hazard Analysis.
Requirements:
· Performance management.
· Project Management proficiency
· Knowledge of firmware and software controls
· Coaching.
· Process improvement.
· Decision making.
· Strategic planning.
· Developing standards.
· Quality Management.
· Proficient in Medical Device design controls practices and requirements
· Decision making based on scientific data
· Ability to influence, motivate, employees, stakeholders and senior leadership
· Successful track record in developing and managing technology life cycles in a manufacturing environment
· Excellent problem solving, organizational, analytical, and critical thinking skills with a high degree of discretion and judgement
EDUCATION AND EXPERIENCE:
Bachelor’s degree in Engineering, Ten (10) years’ experience as a Design Engineer. Five (5) + years’ experience of Engineering and Product Development management in the medical device field in a manufacturing environment
We are an Equal Employment Opportunity (“EEO”) Employer.
Pro-Dex is 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. Pro-Dex makes hiring decisions based solely on qualifications, merit, and business needs at the time.
Job Type: Full-time
Pay: $175,000.00 - $210,000.00 per year
Benefits:
- 401(k)
- 401(k) matching
- Dental insurance
- Employee assistance program
- Flexible spending account
- Health insurance
- Life insurance
- Paid time off
- Professional development assistance
- Tuition reimbursement
- Vision insurance
Compensation package:
- Bonus opportunities
- Stock options
Experience level:
Schedule:
- 8 hour shift
- Monday to Friday
Education:
Experience:
- Engineering and Product development: 5 years (Required)
- Design Engineer: 10 years (Required)
Language:
Ability to Relocate:
- Irvine, CA 92614: Relocate before starting work (Required)
Work Location: In person