Product Development Engineer

Renerva, Inc.; Pittsburgh, Northern (Allegheny County, KY); Hybrid; USD 90,000 - 130,000; Full time

Job summary

Renerva, LLC is hiring a Product Development Engineer to lead the design, prototyping, and testing of implantable medical devices in a fast-paced, on-site Pittsburgh setting.

You will drive rapid prototyping, automate mechatronics, and manage cross-functional teams through the full engineering lifecycle, ensuring robust data for regulatory submissions and manufacturing readiness.

Qualifications

• Education: BS or MS in Mechanical Engineering, Biomedical Engineering, or related fields.
• Experience: Minimum of 3 years of product development experience in the medical device industry.
• Automation & Electronics: Hands-on experience with microcontrollers (e.g., Arduino) and integrating motors and sensors.
• Prototyping: Proficient in 3D modeling, STL/FDMed printing, CNC machining (3‑, 4‑axis), laser cutting, and assembly.
• Quality & Regulatory: Knowledge of ISO 13485 and FDA 21 CFR 820.

Responsibilities

• Lead design, prototyping, manufacturing, and testing of implantable medical devices.
• Translate user needs and regulatory requirements into viable device designs with rapid iteration.
• Design and assemble custom hardware/controllers; integrate stepper motors, servos, and sensors.
• Develop testing methodologies across mechanical, physical, chemical, and biological domains.
• Source and manage external machining vendors; act as primary technical liaison.
• Own engineering project lifecycles: cost projection, resource management, cross‑functional coordination.
• Oversee SOPs, product documentation, and regulatory memos for submissions.

Skills

Automation & Electronics

Prototyping

Project Leadership

Cross-functional Collaboration

Analytical Thinking

Education

Bachelor's in Mechanical or Biomedical Eng

MS in Mechanical/BioMed Eng

Tools

Arduino

3D CAD

3D Printing

CNC Machining

Laser Cutting

Job description

We are a fast-paced implantable medical device company currently transitioning from the clinical stage to commercialization. Mid-way through a pilot clinical study and actively preparing an FDA submission for market clearance, we are at a critical juncture and require a high-impact player to drive our technical operations.

We are seeking a highly driven Product Development Engineer with proven experience and expertise in technical developments for the medtech industry. Operating within a mature Quality Management System, this role demands an agile, systems-level thinker who thrives at the intersection of R&D, product development, mechatronics, and project management.

Responsibilities:

R&D & Rapid Prototyping: Act as the technical lead to manage and participate in the design, prototyping, manufacturing, and testing of implantable medical devices. Transform user inputs and regulatory requirements into viable device designs, utilizing rapid prototyping tools to iterate quickly.

Automation & Mechatronics: Design and assemble custom hardware and controllers (e.g., Arduino-based platforms). Integrate and control stepper motors, servos, and sensors to build custom bioreactors, test fixtures, and specialized R&D equipment.

Test Engineering: Develop comprehensive testing methodologies from scratch. Execute the mechanical, physical, chemical, and biological testing of medical devices, ensuring robust data collection and analysis.

Tooling & External Vendor Management: Design specialized tooling for both commercial manufacturing and the testing of medical devices. Source, evaluate, and direct external machining providers to manage the fabrication of these tools, acting as the primary technical liaison.

Technical Project Management: Own the lifecycle of engineering projects. Accurately project costs, manage resources, and oversee external consultants. Lead multidisciplinary technical discussions with clinical, research, and production staff.

Rigorous Documentation: Oversee the writing of standard operating procedures, product documentation, and ensure detailed oriented record keeping and technical documentation. Produce high-level engineering reports and technical memos that support regulatory submissions to federal agencies.

Qualifications

Education: BS or MS in Mechanical Engineering, Biomedical Engineering, or related fields.

Experience: Minimum of 3 years of Product development experience in the medical device industry.

Automation & Electronics Expertise: Proven hands‑on experience building automated systems, working with microcontrollers (e.g., Arduino), and integrating steppers, servos, and sensor arrays.

Prototyping Proficiency: Deep knowledge of 3D modeling of complex components and assemblies. Extensive practical experience with 3D printing (both with STL and FDM systems), CNC Machining (3‑axis and 4‑axis systems), laser cutting and engraving, and basic machining and assembly.

Quality & Regulatory: Strong working knowledge of Quality Management System (ISO 13485 and FDA 21 CFR 820).

Problem Solving & Leadership: Strong analytical, creative, and decision-making skills. Capable of independent technical leadership, vendor management, and cross‑functional collaboration.

Work Authorization: Candidates must hold permanent U.S. Employment Authorization.

Location: This position is strictly 100% on‑site in Pittsburgh, PA. Remote or hybrid work is not available. Due to the immediate, fast‑paced needs of our current clinical stage, local candidates are highly preferred.

Application Instructions

If you meet our requirements and are ready to be our go‑to technical expert, please submit the following via email at [e-mail]:

A brief cover letter detailing your specific medical device background, your hands‑on experience with mechatronics/automation, and why you are the ideal fit

Your resume

A list of three professional references with their contact information

We will be in touch with all candidates within 1-2 weeks from receiving the aforementioned information.