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Biomedical Engineer, Medical Devices

Hydro Flask

Hydro Flask

Marlborough, MA, USA
Posted on Friday, May 31, 2024

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: Biomedical Engineer, Medical Devices

Department: Engineering

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 responsible for evaluation of the design of proposed medical device products along with development and evaluation of such products. This role will also be responsible for development of Verification and Validation methods for medical products to ensure they meet intended use in addition to specification needs. Evaluations of practicality from a Biomedical viewpoint will be required and a background in Biomedical engineering is strongly preferred.

A major component of this role will 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 member across multiple programs working to tackle product design development problems and improvements
  • Maintain and create DHF files and reports for new and existing products
  • Lead 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
  • Development, 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. …)

Skills needed to be successful in this role:

  • Must be familiar with SW fundamentals and IEC 62304 standard for medical device SW
  • Must possess proactive attitude and be a self-starter in exploring new products and technologies
  • 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

Minimum Qualifications:

  • Bachelor's Degree in Biomedical Engineering or equivalent experience
  • 2+ years of experience conducting product development in a regulated industry
  • 2+ years of experience in consumer product development
  • Be able to coordinate product development activities in all phases of the NPD process, including technical feasibility, prototyping, testing, designing, and performance, and feature validation and verification through pilot run and initial production
  • Must be capable of preparing formal review reports for proposed projects
  • Ability to analyze correlations between a multitude of variables and draw meaning
  • Ability to create a MATLAB (or equivalent program) pipeline to process raw data and output variables of interest
  • 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

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 brands! Have the confidence to come as who you are because your point of view, skills, and experience will make us stronger. If you're eager to share new ideas and try new things, we want to hear from you.

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For more information about Helen of Troy, visit www.helenoftroy.com. You can also find us on LinkedIn, Glassdoor, Facebook, Instagram and Twitter.

Helen of Troy is an Equal Opportunity/Affirmative Action Employer. We are committed to developing a diverse workforce and cultivating an inclusive environment. We value diversity and believe that we are strengthened by the differences in our experiences, thinking, culture and background. We do not discriminate on the basis of race, color, religion, sex, national origin, sexual orientation, gender identity, age, marital status, disability, protected veteran status or any protected basis.

We will provide individuals with disabilities reasonable accommodation to participate in the job application process. If you would like to request an accommodation, please contact Human Resources at (915) 225-8000.

Founded in 1968, Helen of Troy is a prominent player in the global consumer products industry, offering diverse career opportunities across North America, South America, Europe, and Asia. We boast a collection of renowned brands such as OXO®, Hydro Flask®, Osprey®, Honeywell®, PUR®, Braun®, Vicks®, Hot Tools®, and Drybar® – many of which rank #1, #2, or #3 in their respective categories, making the Helen of Troy name synonymous with excellence and ingenuity.

At Helen of Troy, our strategy involves acquiring brands that we can integrate and enhance, amplifying their unique attributes to drive growth and profitability. Embracing a culture of collaboration internally and externally, we are committed to providing innovative solutions tailored to consumers, operational excellence, global scalability, and exceptional shared services to support our brand portfolio. This dedication to fostering development and success sets Helen of Troy apart as a pioneer in the industry, propelling our brands to unparalleled heights of success and recognition worldwide.

The above statements are intended to describe the general nature and level of work performed by people assigned to this classification. They are not intended to be construed as an exhaustive list of all responsibilities and duties required of personnel so classified. Management retains the right to add or to change duties of the position at any time.