Product Development Engineer 2 - Louisville, CO

Role Summary

Contribute to the development of medical devices from concept through production by applying strong technical judgment, customer-centric design principles, and sound engineering practices. Work on simple to moderately complex design and project tasks with general oversight, receiving close supervision only on unusual or difficult problems.

Knowledge

Technical & Domain Knowledge

• Bachelor’s degree in Biomedical Engineering, Mechanical Engineering, or a related engineering discipline.
• Understanding of medical device product development processes and lifecycle, including concept, design, verification, validation, and manufacturing transfer.
• Working knowledge of:
  • Design for Manufacturability (DFM).
  • Geometric Dimensioning and Tolerancing (GD&T).
  • Tolerance stack-up analysis.
• Familiarity with manufacturing processes such as:
  • Machining
  • Injection molding
  • Common joining methods
  • Rapid prototyping
• Working understanding of risk management principles and tools as applied to medical devices across the product lifecycle.
• Awareness of or exposure to Design for Six Sigma (DFSS) concepts, statistical methods, and design of experiments (DOE).

Tools & Software

• Competent in 3D CAD, preferably SolidWorks.
• Familiarity with statistical software (e.g., Minitab) for data analysis and DOE.

Skills

Technical Skills

• Ability to independently perform simple to moderately complex design tasks and project activities.
• Capable of conducting research and technical investigations to support design decisions.
• Able to formulate and solve engineering problems that require a moderate level of technical knowledge.
• Ability to evaluate, select, and apply standard engineering techniques, procedures, and criteria to perform tasks or sequences of tasks on projects with moderately complex features.
• Strong technical writing skills, with the ability to author engineering reports, protocols, and verification/validation documentation with moderate guidance.

Analytical & Problem-Solving Skills

• Demonstrated problem-solving skills, with a drive to identify root causes and develop practical solutions.
• Ability to apply DFSS tools and statistical methods (including DOE) to support product and process optimization.
• Capable of analyzing tolerance stack-ups and assessing design impacts on manufacturability and performance.

Project & Collaboration Skills

• Ability to interact effectively with project teams, suppliers, customers, contractors, and other stakeholders.
• Supports builds and manufacturing transfer activities, working cross-functionally with operations, manufacturing, and quality.
• Able to prepare and maintain project documentation in a timely and accurate manner.

Communication Skills

• Fast and accurate communication with team members and management.
• Able to explain technical concepts clearly to both technical and non-technical stakeholders.

Behaviors

• Action-oriented and detail-focused: Takes initiative, follows through on tasks, and maintains high attention to detail.
• Continuous learner: Demonstrates an aptitude for technical learning, progressing from limited knowledge in some areas to broader competence across multiple practice areas.
• Quality and customer focus: Designs with end-user needs and quality requirements in mind, applying risk management tools to identify, assess, and mitigate risks.
• Collaborative: Works constructively within cross-functional teams and with external partners (suppliers, contractors, customers).
• Results-driven: Shows a strong drive for results and completion of tasks to a high standard.
• Adaptable: Willing and able to work flexible hours and adjust to changing project needs and priorities.

Experience

• Bachelor’s Degree; approximately 2 years of work experience in health and/or business-related environments
  OR
• Master’s Degree; 0–2 years of work experience in health and/or business-related environments.

Relevant experience should include some combination of:

• Participation in medical device or related product development projects (from concept to verification/validation and/or manufacturing transfer).
• Hands-on involvement with engineering builds, prototyping, and/or manufacturing process support.
• Preparation of engineering documentation (reports, test protocols, test reports, risk assessments, etc.).
• Use of CAD tools and basic statistical methods in an engineering context.

Physical & Work Requirements

• Regularly required to sit, stand, walk, reach with hands and arms, use hands to finger, handle, or feel; must be able to talk and hear.
• Specific vision requirements include close vision, color vision, and the ability to adjust focus.
• Ability to lift or move up to 25 pounds.
• Ability to work flexible hours as needed.
• Ability to travel up to 10% as required.

Why Hologic?

At Hologic, we’re driven by a passion for innovation and a commitment to improving patient outcomes. As part of our team, you’ll play a pivotal role in bringing breakthrough RFA technology to healthcare facilities, empowering clinicians, enhancing patient care, and transforming the standard of women’s health. Here, your leadership will be valued, your ideas heard, and your growth supported

The annualized base salary range for this role is $78,000-122,100 and is bonus eligible. Final compensation packages will ultimately depend on factors including relevant experience, skillset, knowledge, geography, education, business needs and market demand.

Agency And Third Party Recruiter Notice

Agencies that submit a resume to Hologic must have a current executed Hologic Agency Agreement executed by a member of the Human Resource Department. In addition, Agencies may only submit candidates to positions for which they have been invited to do so by a Hologic Recruiter. All resumes must be sent to the Hologic Recruiter under these terms or they will not be considered.

Hologic’s employees are subject to third-party COVID-19 vaccination requirements, including from customers and governmental entities. Hologic is an equal opportunity employer and consistent with federal, state, and local requirements, will consider requests for reasonable accommodation based on disability or sincerely-held religious beliefs where it is able to do so without undue hardship to the company.

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

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