Sr. New Product Development Engineer

Biomerics LLC; Brooklyn Park (MN); On-site; USD 80,000 - 100,000; Full time

Benefits offered by this job

Medical/Dental/Vision Insurance

401(k)

Paid Vacation Days

Job summary

Biomerics LLC is seeking a Senior NPD Engineer to lead the innovative design and development of medical devices from concept through commercialization. In this role, you will focus on product architecture and technical problem-solving while collaborating with cross-functional teams and mentoring junior engineers.

The ideal candidate will have a Bachelor’s degree in Engineering and 5–8 years of experience in medical device design, along with proficiency in 3D CAD. The position offers a comprehensive benefits package, including medical insurance and a 401(k) plan.

Qualifications

• 5–8 years of medical device design experience.
• Strong knowledge of design controls and verification/validation methods.
• Demonstrated ability to lead design efforts independently.

Responsibilities

• Lead design and development across the product lifecycle.
• Translate customer requirements into product designs.
• Evaluate and integrate new materials and technologies.

Skills

Medical device design experience

Design controls knowledge

3D CAD proficiency (SolidWorks preferred)

Analytical and statistical tools

Technical writing skills

Cross-functional collaboration skills

Education

Bachelor’s degree in Engineering

Tools

SolidWorks

Job description

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. The 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 the development of new product concepts, technologies, and design solutions
• Evaluate and integrate 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 the 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

Process Improvement & Business Support

• 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

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 a 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
• Six Sigma Green/Black Belt (preferred)

Benefits

• Medical/Dental/Vision Insurance
• Short-Term Disability
• Long-Term Disability
• Life Insurance
• Paid Vacation Days
• Paid Holidays
• 401(k)