Project Engineer, Medical Devices

Join our Engineering team at Helen of Troy and make an immediate impact on our trusted brands : OXO, Hydro Flask, Osprey, Honeywell, PUR, Braun, Vicks, Hot Tools, Drybar, Curlsmith, and Revlon.

Together, we build innovative and useful products that elevate people's lives everywhere every day.

Look around your home, and you'll find us everywhere, in your kitchen, living room, bedroom, and bathroom. We are already making your everyday lives better.

We are powered by knowledgeable, 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 for Braun and Vicks

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

Hybrid Schedule : Helen of Troy associates enjoy the advantages and flexibility of a hybrid working model, allowing for in office 3 days minimum, and remote 2 days.

Any changes to this working model would be communicated accordingly.

What you will be doing :

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 member across multiple programs working to tackle product design development problems and improvements.
• Maintain and build DHF files and reports for new and existing products.
• Lead or coordinate 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 insights 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 multi-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..

Skills needed to be successful in this role :

• Be able to coordinate product development activities in all phases of the NPD process, including evaluating technical feasibility, prototyping, testing, designing, and measuring performance.
• Possess knowledge of consumer product development processes.
• Proficient with SW fundamentals and IEC 62304 standard for medical device SW.
• Possess proactive attitude and be a self-starter in exploring new products and technologies.
• Ability to balance 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.

Minimum Qualifications :

• 3+ years of experience conducting product development in a regulated industry medical devices preferred
• 3+ years of experience in consumer product development
• BS Degree in Biomedical, Mechanical, or Electrical Engineering or equivalent experience
• Limited travel is required up to 15%
• Authorized to work in the United States on a full-time basis

Preferred Qualifications :

• Master’s Degree
• Hands on Circuit Design and PCBA design experience
• Understanding of UL / ETL / FDA / CE general requirements
• Ability to create a MATLAB (or equivalent program) pipeline to process raw data and output variables of interest

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.