Sr. Product Development Engineer - Louisville, CO

Hologic•Louisville, CO

28d

About The Position

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.

Requirements

Bachelor's degree in Biomedical Engineering, Mechanical Engineering, or a related field, with 5+ years in product development or medical device industry; or Master's degree with 3+ years in similar roles.
Track record leading small to medium-sized projects and managing subsystems.
Experience defining project scope, budget, and schedules, and driving project planning.
Demonstrated capability in developing new techniques, processes, materials, or products.
Comprehensive understanding of engineering principles, especially within Biomedical Engineering, Mechanical Engineering, or related fields.
In-depth knowledge of product development processes and medical device industry standards.
Familiarity with risk management practices throughout the product lifecycle.
Expertise in manufacturing processes, such as machining, injection molding, joining methods, and rapid prototyping.
Advanced proficiency in CAD software (SolidWorks preferred).
Strong grasp of experimental design, computational analysis, and statistical methods (DFSS, DOE, MiniTab).
Knowledge of tolerance stack-up analysis, Design for Manufacturability (DFM), and Geometric Dimensioning and Tolerancing (GD&T).
Awareness of clinical applications, especially in gynecological surgery or related surgical spaces.
Technical leadership: Ability to oversee projects and subsystems, ensuring timely delivery and alignment with milestones.
Task management: Assigns, delegates, and guides engineers, technicians, and administrative staff.
Mentorship: Actively supports the professional growth of junior engineers.
Technical problem solving: Independently formulates and resolves complex engineering challenges.
Technical documentation: Prepares comprehensive reports, protocols, requirements, and risk documentation with minimal supervision.
Communication: Clearly, promptly, and accurately conveys information to teams and management.
Analytical skills: Applies advanced computational and statistical tools to support experimental design and data analysis.
Cross-functional collaboration: Builds strong relationships across teams to foster a collaborative and engaged culture.
Systems thinking: Demonstrated ability to design medical devices considering the entire system.
Customer-centric mindset: Prioritizes user experience and real-world customer needs in all aspects of product design.
Detail-oriented: Maintains a high level of accuracy and thoroughness in technical work.
Action-oriented: Takes initiative and drives results persistently.
Quality-focused: Reviews project documentation to ensure compliance and excellence.
Proactive risk management: Identifies, assesses, and mitigates risks effectively.
Collaborative and supportive: Fosters teamwork, shares knowledge, and encourages open communication.
Professional and ethical: Adheres to company policies, confidentiality, and regulatory requirements.
Physical ability to sit, stand, walk, reach, handle objects, and lift/move up to 25 pounds.
Willingness and ability to travel up to 10% as needed.

Nice To Haves

Prior involvement with medical device tissue testing and model development (desired).
Experience with Radio Frequency Ablation (RFA) techniques and optimizing power output or algorithms for RF/microwave generators (desired).
Strong clinical and technical experience in gynecological surgery or an applicable surgical technology (desired).

Responsibilities

Oversee projects and subsystems, ensuring timely delivery and alignment with milestones.
Assigns, delegates, and guides engineers, technicians, and administrative staff.
Actively supports the professional growth of junior engineers.
Independently formulates and resolves complex engineering challenges.
Prepares comprehensive reports, protocols, requirements, and risk documentation with minimal supervision.
Clearly, promptly, and accurately conveys information to teams and management.
Applies advanced computational and statistical tools to support experimental design and data analysis.
Builds strong relationships across teams to foster a collaborative and engaged culture.
Demonstrated ability to design medical devices considering the entire system.