Sr. Product Development Engineer

Company Overview

Biomerics is a world‑class manufacturer and innovative polymer solutions provider for the medical device and biotech industries. As a vertically integrated company, we specialize in designing, developing, and producing medical devices for diagnostic and interventional procedures. We focus on next‑generation solutions for vascular access, electrophysiology, cardiac rhythm management, neurovascular, structural heart, and cardiovascular markets.

The Senior NPD Engineer is responsible for leading the design and development of complex medical devices from concept through commercialization. This role focuses on product architecture, detailed design, and technical problem solving to deliver innovative, high‑quality solutions that meet customer and business needs.

• Lead design and development activities across the product lifecycle, from concept through design verification and validation.
• Translate customer requirements into detailed product designs, engineering specifications, and functional requirements.
• Develop product architectures, component designs, and assemblies using sound engineering principles.
• Ensure designs meet performance, reliability, manufacturability, and regulatory requirements.
• Drive innovation through development of new product concepts, technologies, and design solutions.
• Evaluate and integrate new materials, technologies, and design approaches to enhance product capability.
• Solve complex design challenges using advanced engineering analysis, simulation, and testing methodologies.
• Design and execute experiments, testing, and analysis to validate product performance and design robustness.
• Apply statistical and analytical tools to support design decisions and optimize product performance.
• Identify technical risks early and lead development of mitigation strategies.
• Apply and ensure adherence to design control processes, including Design History Files (DHF), risk management, and verification/validation activities.
• Ensure compliance with regulatory and quality requirements throughout the design process.
• Lead engineering change activities, ensuring proper documentation and implementation.
• Support accurate and thorough technical documentation across the product lifecycle.
• Collaborate with manufacturing, process engineering, quality, and regulatory teams to ensure successful design transfer and product launch.
• Drive design for manufacturability (DFM) and design for assembly (DFA) throughout development.
• Partner with customers to refine requirements, present design solutions, and support technical discussions.
• Lead significant portions of projects or own key design work streams with full accountability.
• Mentor and provide technical guidance to engineers and designers, supporting team capability development.
• Identify opportunities to improve design processes, tools, and methodologies.
• Contribute to early program planning and quoting by providing input on technical feasibility, risks, and timelines.
• Provide input into quotes to ensure accuracy and quick turnaround.
• Perform other duties as assigned in support of business and organizational objectives.

• Bachelor’s degree in Engineering with 5–8 years of medical device design experience.
• Strong knowledge of design controls, product development, and verification/validation methods.
• Proficiency in 3D CAD (Solid Works preferred) and strong understanding of GD&T/drafting.
• Experience with analytical and statistical tools (DOE, tolerance analysis, etc.).
• Experience in regulated environments.
• Strong technical writing and documentation skills.
• Excellent communication and cross‑functional collaboration skills.
• Demonstrated ability to lead design efforts or major work streams independently.
• Proven ability to mentor junior engineers and guide technical work.
• Six Sigma Green/Black Belt (preferred).

• Medical, dental, and vision insurance.
• Short‑term and long‑term disability.
• Life insurance.
• Paid vacation days and paid holidays.
• 401(k) plan.

Salary
: $120 k – $145 k (estimates only).