R&D Engineer 3

Hologic, Inc.; Louisville (KY); On-site; USD 98,000 - 153,000; Full time

Benefits offered by this job

Competitive salary

Annual bonus scheme

Training and development

Job summary

Hologic, Inc. is seeking a Senior Product Development Engineer to lead the design and development of innovative medical devices from concept through full-scale production, with a strong focus on customer-centric design and quality.

You will mentor engineers, manage risk, define scopes and schedules, and collaborate across functions to deliver robust products that meet real-world needs and regulatory standards.

Qualifications

• Bachelor's degree with R&D experience in the medical device industry.
• 5+ years in new product development and/or the medical device industry with Bachelor’s Degree.
• 3+ years in new product development and/or the medical device industry with Master’s Degree.
• Strong problem-solving and cross-functional collaboration is expected.
• Ability to author protocols, reports, requirements, and risk documentation.

Responsibilities

• Provides technical leadership for small to medium-sized projects, overseeing subsystems and ensuring milestones are met.
• Assigns tasks and provides direction to engineers, technicians, and staff to facilitate project success.
• Mentors and supports junior engineers' development.
• Defines project scopes, budgets, and schedules for assignments and planning.
• Independently resolves complex technical problems with expertise.
• Prepares engineering reports and verification/validation materials; reviews documents for quality and compliance.
• Applies broad risk management expertise across the product lifecycle.
• Drives development of new techniques, processes, materials, or products.
• Builds cross-functional relationships to foster collaboration.

Skills

Technical leadership

Clear communication

Technical writing

CAD - SolidWorks

DFM / GD&T

DOE / DOE analysis

Experiment design

Manufacturing processes

Education

Bachelor's Degree in Biomedical or Mechanical Engineering

Master's Degree in related field

Tools

MiniTab

DOE tools

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.

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.

As part of our commitment to a fair and accurate evaluation of each candidate's qualifications, we require all applicants to refrain from using AI tools, such as generative AI or automated writing assistance, during any stage of the interview process. Responses influenced by AI may result in disqualification. We appreciate your understanding and cooperation in ensuring a transparent and equitable selection process.

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

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