Operations Product Engineer, Medical Devices

Position: Operations Product Engineer, Medical Devices

Department: Engineering (Braun, Vicks)

Work Location(s):

• Marlborough, MA

• New York, NY

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. Please note that hybrid eligibility and schedules may vary based on business needs and manager expectations.

What you will be doing:

The Operations Product Engineer will serve as the primary technical owner for sustaining engineering activities on assigned consumer medical products (Braun and Vicks products). This role will be responsible for developing test plans, reviewing test reports and process validation documents, and drafting technical memos for medical products to ensure they meet intended use and specification needs. 

A major component of this role will be supporting sustaining engineering projects through technical investigations, design changes, documentation updates, and cross-functional problem solving.

• Maintain DHF documentation and design history records for existing products.

• Assess product changes and determine required verification, validation, and documentation activities

• Work with engineering, program management, regulatory, quality, supply chain and marketing teams on sustaining engineering

• Perform component and system failure analysis with Quality.

• Lead technical reviews and verification testing.

• Work with accredited test laboratories to support product testing and regulatory compliance activities, including biocompatibility, electrical safety, and performance evaluations.

Skills needed to be successful in this role:

• Strong communication skills with the ability to deliver clear, concise project updates and direction to technical and non-technical audiences, including non-native English speakers.

• Ability to manage multiple priorities in a fast-paced environment while remaining flexible and adaptable.

• Proactive, self-driven mindset with a strong sense of ownership and initiative.

• Strong problem-solving skills, attention to detail, and commitment to quality.

• Self-motivated learner with a track record of independently developing new technical skills and knowledge to solve engineering challenges.

• Collaborative team player who thrives in cross-functional environments.

• Passion for applying engineering expertise to drive meaningful business impact.

Minimum Qualifications:

• Bachelor’s degree in Biomedical Engineering, Mechanical Engineering, or a related technical field.

• 2+ years of experience in sustaining engineering, product development, and/or manufacturing.

• Experience working within a regulated industry.

• Experience  supporting healthcare consumer products, consumer electronics products, medical devices or similar electromechanical products.

• Knowledge of ISO 13485 and IEC 60601 standards.

• Proficiency with CAD tools (SolidWorks, Creo, or similar), prototyping, and 3D printing.

• Experience with manufacturing processes, including injection molding, sheet metal fabrication, silicone molding, and die casting.

• Ability to travel domestically/internationally up to 15% (China, Mexico, Thailand, and Vietnam).

• Authorized to work in the United States on a full-time basis.

Preferred Qualifications:

• Familiarity with software and firmware development concepts and ability to collaborate with software engineering teams

• Understanding of UL/ETL/FDA/CE/NMPA general requirements.

• Hands on Circuit Design and PCBA experience.

In Massachusetts and New York, the standard base pay range for this role is $84,000 -$100,000 annually. This base pay range is specific to Massachusetts/New York 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 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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The above statements are intended to describe the general nature and level of work performed and are not intended to be an exhaustive list of responsibilities.

Management reserves the right to modify the duties and responsibilities of the position at any time.