Sr. New Product Development Engineer

Description

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 are focused on next-generation solutions for vascular access, electrophysiology, cardiac rhythm management, neurovascular, structural heart, and cardiovascular markets.

At Biomerics, we are dedicated to our diverse employee base. We understand that a strong, skilled, and engaged workforce is the foundation of our continued success as a business. We strive to live up to the Biomerics values in all our interactions. It is an exciting time to be part of our collective team, and there is no limit to the impact that can be achieved here at Biomerics.

We improve and advance our employees' lives and the lives of the patients who depend on our products.

At Biomerics, we are guided by our core values of integrity, partnership, empowerment & accountability, trust, agility, teamwork, and excellence. We deeply care about our team members and customers, and our team-oriented, customer-focused corporate culture places a premium on building strategic, mutually beneficial partnerships. Joining our team means becoming part of a dynamic, innovative, and caring community.

 Job Summary

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.

Operating with a high level of independence and technical expertise, the Senior Engineer leads key design efforts, collaborates closely with customers and cross-functional teams, and ensures designs are robust, manufacturable, and compliant with regulatory requirements. This role also plays a critical part in mentoring engineers and driving continuous improvement in product design practices.

Role Responsibilities

Product Design & Development

• 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 
• Evaluates and integrates new materials, technologies, and design approaches to enhance product capability.

Engineering Analysis & Problem Solving

• 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 
• Evaluate and integrate new materials, technologies, and design approaches 

Design Controls & Compliance

• 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

Change Management & Documentation

• Lead engineering change activities, ensuring proper documentation and implementation 
• Support accurate and thorough technical documentation across the product lifecycle 

Cross-Functional Collaboration & Customer Engagement

• 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 

Leadership & Project Ownership

• Lead significant portions of projects or own key design workstreams with full accountability 
• Mentor and provide technical guidance to engineers and designers, supporting team capability development