R&D Engineer 3

DIRECT SALES, US; Louisville (CO); On-site; USD 98,000 - 153,000; Full time

Job summary

Hologic, Inc. in Colorado, United States, seeks a Senior Product Development Engineer to drive design and development of innovative medical devices from concept to full production, emphasizing customer-centered design and superior user experiences.

You will mentor junior engineers, define project scopes, budgets and schedules, and produce engineering documentation for verification and regulatory readiness, applying risk management and rigorous design-for-manufacturing principles.

Qualifications

• Bachelor's or Master’s degree with R&D experience in medical devices.
• 5+ years in new product development in medical devices with Bachelor's.
• 3+ years in new product development in medical devices with Master's degree.

Responsibilities

• Provide technical leadership for projects with subsystems.
• Mentor junior engineers and guide team members.
• Define scopes, budgets, and schedules for assignments.
• Prepare engineering reports and verification/validation materials.
• Apply risk management to lifecycle activities.
• Collaborate with cross-functional teams to ensure quality and compliance.

Skills

Technical leadership

Communication

Technical writing

DFM & GD&T

SolidWorks CAD

MiniTab/DOE

Education

BS in Biomedical/Mechanical Engineering

MS in Engineering

Tools

SolidWorks

MiniTab

Job description

The Senior Product Development Engineer leverages extensive technical expertise and sound judgment to lead the design and development of innovative products from initial concept through to full-scale production. With a strong focus on customer-centric design principles, this role ensures that products deliver exceptional user experiences and address real-world customer needs.

Essential Duties and Responsibilities:

• Provides technical leadership for small to medium-sized projects, overseeing one or more subsystems and ensuring both short-term and long-term deliverables align with project milestones.
• Assigns tasks and provides direction to engineers, technicians, and administrative staff to facilitate successful project execution.
• Actively mentors and supports the professional development of junior engineers.
• Contributes to defining project scopes, budgets, and schedules for assignments and overall project planning.
• Independently formulates and resolves complex technical problems, leveraging expertise and specialized skillsets.
• Prepares comprehensive project documentation, including engineering reports and verification/validation materials; reviews all project documents to ensure quality and compliance.
• Applies broad expertise in risk management to proactively identify, assess, and mitigate risks throughout the product lifecycle.
• Conducts research and drives the development of new techniques, processes, materials, or products to enhance project outcomes.
• Builds and maintains strong cross-functional relationships, fostering a collaborative and engaged team culture.

Qualifications and Experience

• Bachelor's Degree in Biomedical Engineering, Mechanical Engineering, or a related field with research and development experience in the medical device industry.
• 5+ years of work experience in new product development and/or the medical device industry with Bachelor’s Degree
• 3+ years of work experience in new product development and/or the medical device industry with Master’s Degree

Required Skills:

• Action and detail oriented with an aptitude for technical learning
• Communicates clearly, promptly, and accurately with team members and management.
• Possesses robust functional and technical capabilities, strong problem-solving skills, and a persistent drive for results.
• Skilled in technical writing, able to independently author protocols, reports, requirements, and risk documentation with minimal supervision.
• Well-versed in manufacturing processes, including machining, injection molding, common joining methods, and rapid prototyping.
• Experienced in experimental design, computational analysis, and the application of analytical tools such as DFSS and statistical methods, including Design of Experiments (DOE) and MiniTab.
• Proficient in tolerance stack-up analysis, Design for Manufacturability (DFM), and Geometric Dimensioning and Tolerancing (GD&T).
• Advanced CAD skills, with proficiency in SolidWorks preferred.

Desired Skills:

• Experience with Radiofrequency Ablation (RFA) techniques and related clinical applications.
• Familiarity with energy delivery, tissue testing, and the development of tissue models.
• Demonstrated experience developing electromechanical medical devices, including the design and development of both disposable and reusable instruments.
• Strong clinical and technical knowledge and skills within the field of gynecological surgery, or an applicable surgical space or technology.
• Experience translating clinical, physician, and customer requirements into product specifications and design requirements.

Physical Demands:

The physical requirements described here are representative of those that must be met by an employee to successfully perform the essential functions of this job.

• The employee is regularly required to sit, stand, walk, and reach with hands and arms, use hands to finger, handle, feel, and be able to talk and hear.
• Ability to lift or move up to 25 pounds.

Travel:

• Ability to travel as necessary up to 10%.

So why join Hologic?

We are committed to making Hologic the company where top talent comes to grow. For you to succeed, we want to enable you with the tools and knowledge required and so we provide comprehensive training when you join as well as continued development and training throughout your career. We offer a competitive salary and annual bonus scheme, one of our talent partners can discuss this in more detail with you.

The annualized base salary range for this role is $97,600 - $152,700 and is bonus eligible. Final compensation packages will ultimately depend on factors including relevant experience, skillset, knowledge, geography, education, business needs and market demand.

Hologic, Inc. is proud to be an Equal Opportunity Employer inclusive of disability and veterans.