Medical Device Product Engineer

Job Title: Product Engineer

Location: Reno, Nevada, United States

Job-Type: Full-Time

Experience: Mid to Senior-Level

About Us:

OMEC Medical NV is an innovative medical device company dedicated to developing complete solutions to accelerate patient recovery and reduce operating room costs. We're a fast-paced, collaborative, and mission-driven team committed to bringing life-changing technology to patients. As we expand our product portfolio, we are seeking a Product Engineer with a strong foundation in medical device design, a structured engineering mindset, and the drive to take ownership of product development from concepts through launch and beyond.

Position Summary:

We're looking for a driven Medical Device Product Engineer to join our growing team. You'll be a key player in taking our medical device concepts from early-stage conceptual development through verification, validation, and transfer to manufacturing, applying a systematic and disciplined approach to every challenge. This role requires a hands-on engineer with strong design competencies, a passion for medical technology, a deep understanding of risk management, and robust design planning methodologies. Crucially, you'll possess strong clinical and product knowledge, enabling you to effectively translate user input into actionable design specifications. You'll thrive in an agile, startup environment, demonstrating effective autonomy through strong project management, clear communication, and an astute understanding of when to escalate issues, all while ensuring adherence to regulatory requirements (21 CFR, EU MDR), standards (IEC 60601-1, ISO 14971), and various best practices (cGMP, etc.).

Key Responsibilities

• Design for Product Lifecycle: Manage product requirements through all phases of development, including design planning (design inputs and outputs, DVVP), technical documentation (CAD models, drawings, test cases), design transfer (production qualification), and post-market support (root-cause, COGS reduction, etc.). Ensure all designs and development activities inherently meet stringent regulatory requirements (traceability, etc.) within a design controls process, and support preparation for regulatory submissions (510(k), Tech File, PMA, etc.)
• Clinical/Product Knowledge into User Inputs: Leverage your clinical and/or product knowledge to effectively interact with surgeons, nurses, and other users. You'll be adept at gathering and interpreting user feedback, clinical needs, and operational requirements, then translating this critical input into clear, concise user needs, system requirements, specifications and design outputs, testing, and reports that align with regulatory expectations.
• Design Proficiency: Demonstrate proficiency regarding all aspects of medical device design, including but not limited to device classification, tolerance analysis, GD&T, critical dimensions, DFX, manufacturing considerations, sterilization methods, labeling, etc. to allow for expedient prototyping, verification, and validation cycles. This includes ensuring proactive compliance with relevant performance and safety standards such as ISO 10993, IEC 60601-1, IEC 62304.
• Risk Management & Design Planning Leadership: Actively contribute to and lead aspects of risk management activities throughout the design process in accordance with ISO 14971. This includes hands-on experience with developing Risk Management Plans (RMP), performing Design Failure Mode and Effects Analysis (DFMEA), and supporting Hazard Identification (HID) documentation. Ensure robust risk mitigation strategies are integrated into the design and validated, and that risk documentation is compliant with global regulations.
• Cross-Functional Collaboration & Communication: Work seamlessly with our network of global R&D teams, Quality, Regulatory Affairs, Manufacturing, and Supply Chain teams to integrate engineering efforts, resolve technical challenges, and ensure alignment across all phases of product development into manufacturing. This includes effective communication of technical concepts to non-technical stakeholders, including clinical users, business development, and regulatory bodies as needed.
• Effective Project Autonomy & Management: Drive assigned engineering projects and tasks with a high degree of autonomy, managing your workload effectively to meet aggressive timelines. Take ownership of deliverables, from initial planning through execution, and proactively identify and discern potential roadblocks.

Qualifications

• Bachelor's degree in mechanical engineering, electrical engineering, biomedical engineering, or a related engineering field.
• 5-10 years of hands-on experience in medical device product development engineering.
• Strong working knowledge and practical experience with medical device regulations (at minimum US 21 CFR) and standards, including: ISO 13485, ISO 14971, ISO 10993, ISO 11135, IEC 60601-1, IEC 62304, IEC 81001-5-1
• Strong proficiency in authoring and interpreting User Needs, Risks, Requirements, Specifications, Work Instructions, and Test documentation.
• Solid understanding and practical experience with Design Control principles and their application throughout the product lifecycle. This includes a robust set of approaches for solving complex design challenges.
• Excellent communication skills, particularly in translating complex engineering ideas into relevant languages for a diverse audience (technical, clinical, and leadership), including a keen understanding of when to effectively escalate issues, providing relevant data and proposed solutions.
• Demonstrated ability to effectively manage projects independently, prioritize tasks, and drive deliverables to completion. 

What We Offer

• The opportunity to make a tangible impact on the design and development of new, innovative medical devices, directly influenced by clinical insights, within a supportive environment that values your autonomy.
• A collaborative and challenging work environment where your systematic approach, design expertise, risk management acumen, clinical understanding, project leadership, and collaboration with the team will be highly valued.
• Competitive salary and comprehensive benefits package.
• The chance to contribute to products that genuinely improve lives.

OMEC Medical NV is an Equal Opportunity Employer.