Project Engineer, Medical Devices

Overview

Join our Engineering team at Helen of Troy and make an immediate impact on our trusted brands:
Braun, Vicks. Together, we build innovative and useful products that elevate people s lives everywhere every day.

Look around your home, and you ll find us in your kitchen, living room, bedroom, and bathroom. We are powered by knowledgea ble, enthusiastic, and forward-thinking people committed to developing a culture of inclusion. Whether you are just starting your career or in need of a challenge, we recognize, develop, and empower talent!

Position: Project Engineer, Medical Devices

Department: Engineering (Braun, Vicks)

Work Location: Marlborough, MA, Hybrid (work 3 days onsite)

Hybrid

Schedule:

At Helen of Troy, we embrace a flexible hybrid work model designed to support collaboration and productivity. For roles eligible for hybrid work, our standard schedule includes in-office collaboration from Tuesday through Thursday, with the option to work remotely on Mondays and Fridays. Any updates to this model will be communicated in advance. Hybrid eligibility and schedules may vary based on business needs and manager expectations.

The Project Engineer will be the technical and/or program lead for design, development, and evaluation of consumer medical products. This role will also be responsible for development of Verification and Validation methods for medical products to ensure they meet intended use and specification needs. A major component of this role will also be to fulfill project engineer responsibilities on a per-project basis, including the creation and maintenance of DHF documentation and oversight of technical resolution activities.

• Technical product team lead or members across multiple programs working to solve product design development problems and improvements.
• Maintain and create DHF files and reports for new and existing products.
• Lead or oversee the technical design of product components based upon design requirements.
• Work with engineering and marketing teams on new product development and sustaining engineering.
• Investigation/understanding of competitive designs.
• Perform component and system failure analysis with Quality.
• Develop, support, or perform usability studies to test new ideas and concepts.
• Work with Regulatory to develop and support new clinical studies.
• Support 510K and CE registration filings with Regulatory.
• Interface and work with other members of the cross-functional team, including electrical and software engineers, marketing, sales, and operations.
• Lead technical reviews and testing verifications. Develop and test systems and functions.
• Work with outside testing houses for compliance testing (biocompatibility, safety, performance, FDA, etc.).

• Be able to coordinate product development activities in all phases of the NPD process, including evaluating technical feasibility, prototyping, testing, designing, and measuring performance.
• Ability to handle multiple projects and remain flexible and adaptable.
• Strong communication skills. Must have the ability to provide concise and accurate status and direction on projects, written and verbal.
• Must possess proactive attitude and be a self-starter in exploring new products and technologies.

• Bachelor s degree in biomedical, Mechanical, or Electrical Engineering or related technical field.
• 3+ years of experience conducting product development in a regulated industry.
• 3+ years of experience in consumer product development.
• Must be capable of drafting formal Verification and Validation plans for hardware.
• Must be capable of preparing formal review reports for proposed projects.
• Ability to travel up to 15% (international and domestic).
• Authorized to work in the United States on a full-time basis.

• Master’s degree.
• Evaluations of the practicality from a Biomedical viewpoint will be required and a background in Biomedical Engineering.
• Ability to create a MATLAB (or equivalent program) pipeline to process raw data and output variables of interest.
• Familiarity with SW fundamentals and IEC 62304 standard for medical device software.
• Understanding of UL/ETL/FDA/CE general requirements.
• Hands on Circuit Design and PCBA design experience.

In Massachusetts, the standard base pay range for this role is $82,170.00 - $ annually. This base pay range is specific to Massachusetts and may not be applicable to other locations. Actual salaries will vary based on several factors, including but not limited to location, experience, skill level, and performance. The range listed is just one component of the total compensation package for employees.

Benefits: Salary + Bonus, Healthcare, Dental, Vision, Paid Holidays, Paid Parental Leave, 401(k) with company match, Basic Life Insurance, Short Term Disability (STD), Long Term Disability (LTD), Paid Time Off (PTO), Paid Charitable (volunteer) Leave, and Educational Assistance.

Wondering if you should apply? Helen of Troy welcomes people as diverse as our…