R&D Engineer 3

Hologic, Inc.; Louisville (CO); Hybride; USD 98 000 - 153 000; Plein temps

Résumé du poste

Hologic, Inc. seeks a Senior Product Development Engineer to lead medical device design from concept to production, with a strong focus on customer-centric design and user experience.

You will mentor junior engineers, manage project scopes and schedules, drive risk management and verification/validation, and collaborate across functions to deliver high-quality products. Proficiency in SolidWorks, GD&T, tolerance analysis, and DOE/DFSS is required; gynecologic device experience is a plus.

Qualifications

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

Responsabilités

• Lead design and development of medical devices from concept to production
• Mentor engineers and assign tasks to team
• Define project scopes, budgets, and schedules
• Develop and resolve complex technical problems
• Prepare engineering reports, verification/validation materials
• Apply risk management across product lifecycle
• Drive cross-functional collaboration
• Develop new techniques, processes, or materials
• Maintain project documentation and quality compliance

Connaissances

Technical leadership

Clear communication

Problem solving

Technical writing

Manufacturing processes

Design of Experiments (DOE)

Tolerance analysis

DFM & GD&T

SolidWorks

CAD skills

Formation

Bachelor's in Biomedical Engineering or Mechanical Engineering

Master's degree in related field

Outils

Minitab

Description du poste

TheSenior 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.

Job Summary: Senior Product Development Engineer possessing strong technical judgment and a deep understanding of customer centric design to support new product development from concept to production. Essential Duties ...