Sr. New Product Development Engineer

Biomerics•Brooklyn Park, MN

15h

About The Position

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. 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.

Requirements

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 (SolidWorks 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 workstreams independently
Proven ability to mentor junior engineers and guide technical work

Nice To Haves

Six Sigma Green/Black Belt

Responsibilities

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.
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
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 workstreams 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
Performs other duties as assigned in support of business and organizational objectives.