Program Manager, Wellness

Health & Home USA•Marlborough, MA

2d•Hybrid

About The Position

The Program Manager, Wellness role requires managing healthcare and wellness New Product Development programs from concept to production. The ideal candidate will have experience in developing consumer, electromechanical products and managing multiple programs on a global basis. This role requires the ability to identify issues, assess technical/program alternatives, and manage risks while keeping programs on track. Take a supporting/lead role in planning, scheduling, and executing New Product Development (NPD) programs in collaboration with suppliers and internal teams. Utilize Helen of Troy New Product Development process to effectively drive program progress and manage risks. Familiarity with Agile process is a plus. Work closely with global cross-functional teams in US, Europe, and China. Communicate to teams effectively on program progress, risks, schedule, costs, quality, and performance. Responsible for technical feasibility assessment, program budget, program schedule, and supplier communication. Manage/create product documentation and specifications to support timely execution. Provide guidance for technical solutions and conduct design reviews, FMEA’s (Failure Mode and Effect Analysis), and risk assessments. Create and maintain accessible program files (Design History File) and appropriate documentation based on established regulatory and quality systems.

Requirements

Bachelor’s degree in Mechanical Engineering, Electrical Engineering, Biomedical Engineering, or equivalent.
3+ years of experience working in consumer goods, medical, or any equivalent regulated industry.
Good technical knowledge of plastic part design, electronics, firmware, and software as used in consumer products.
Proven track record in program management, demonstrating strong organizational skills and attention to details.
Proficient in Microsoft Office Programs (MS Excel, Project, Outlook, Word).
Working knowledge of FDA, ISO, UL, and Design History Files.
Basic knowledge of CAD.
Ability to join virtual meetings in the early morning or evening for international calls as needed outside standard business hours.
Ability to travel internationally (Europe + Asia) (15%).
Authorized to work in the United States on a full-time basis.

Nice To Haves

Familiarity with Agile process is a plus.
Working knowledge of IEC 62304
Understanding of safety requirements and medical device regulatory submission in Europe (MDD/MDR) and USA (FDA).

Responsibilities

Take a supporting/lead role in planning, scheduling, and executing New Product Development (NPD) programs in collaboration with suppliers and internal teams.
Utilize Helen of Troy New Product Development process to effectively drive program progress and manage risks.
Work closely with global cross-functional teams in US, Europe, and China.
Communicate to teams effectively on program progress, risks, schedule, costs, quality, and performance.
Responsible for technical feasibility assessment, program budget, program schedule, and supplier communication.
Manage/create product documentation and specifications to support timely execution.
Provide guidance for technical solutions and conduct design reviews, FMEA’s (Failure Mode and Effect Analysis), and risk assessments.
Create and maintain accessible program files (Design History File) and appropriate documentation based on established regulatory and quality systems.