Product Development Engineer 2 - Louisville, CO

Hologic•Louisville, CO

2d•$78,000 - $122,100

About The Position

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.

Requirements

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

Responsibilities

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.
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.
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.
Fast and accurate communication with team members and management.
Able to explain technical concepts clearly to both technical and non-technical stakeholders.
Takes initiative, follows through on tasks, and maintains high attention to detail.
Demonstrates an aptitude for technical learning, progressing from limited knowledge in some areas to broader competence across multiple practice areas.
Designs with end-user needs and quality requirements in mind, applying risk management tools to identify, assess, and mitigate risks.
Works constructively within cross-functional teams and with external partners (suppliers, contractors, customers).
Shows a strong drive for results and completion of tasks to a high standard.
Willing and able to work flexible hours and adjust to changing project needs and priorities.