Operations Product Engineer, Medical Devices

Helen of Troy•Marlborough, NY

1d•Hybrid

About The Position

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 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! 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.

Requirements

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.
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.

Nice To Haves

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.

Responsibilities

Serve as the primary technical owner for sustaining engineering activities on assigned consumer medical products (Braun and Vicks products).
Develop test plans, review test reports and process validation documents, and draft technical memos for medical products.
Support 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.