Engineering Manager
We are seeking a results-driven Engineering Manager to lead and mentor a team of engineers in the design, development, and lifecycle management of medical devices. This individual will play a key role in driving innovation, ensuring regulatory compliance, and delivering products that meet user needs and quality standards.
Base Pay Range
$120,000.00/yr - $150,000.00/yr
Key Responsibilities
- Lead, mentor, and develop a multidisciplinary engineering team (mechanical, electrical, software, systems).
- Oversee the design, development, and testing of medical devices from concept through commercialization.
- Drive cross‑functional collaboration with R&D, Quality, Regulatory Affairs, Manufacturing, and Marketing teams.
- Manage project timelines, budgets, resources, and risk mitigation strategies.
- Ensure design controls and documentation comply with FDA 21 CFR 820, ISO 13485, and other relevant standards.
- Participate in product architecture and system‑level design decisions.
- Support verification and validation (V&V) planning and execution.
- Facilitate design reviews, technical assessments, and root cause analyses.
- Implement best practices for engineering processes, including design for manufacturability (DFM) and design for reliability (DFR).
- Stay current on industry trends, emerging technologies, and regulatory changes.
Required Qualifications
- Bachelor’s degree in Engineering (Mechanical, Biomedical, Electrical, or related field).
- 5+ years of experience in engineering, including 2+ years in a leadership or management role.
- Proven experience developing and commercializing medical devices.
- Strong knowledge of regulatory requirements (FDA, ISO 13485, IEC 60601, etc.).
- Excellent leadership, communication, and interpersonal skills.
- Demonstrated ability to lead technical teams and manage multiple projects.
Preferred Qualifications
- Master’s degree in Engineering, Business, or related field.
- Experience with Class II or III medical devices.
- PMP certification or formal project management training.
- Experience with product lifecycle management (PLM) tools and Agile development methodologies.
Seniority Level
Mid‑Senior level
Employment Type
Full‑time
Job Function
Research and Manufacturing
Industries
Medical Equipment Manufacturing
Benefits
- Medical insurance
- Vision insurance
- 401(k)
- Paid paternity leave
- Paid maternity leave
- Disability insurance
Location and Compensation
San Antonio, TX – $86,600 - $197,800 – 3 hours ago