Medical Device Tech Lead: DV, NPD & Sustaining

HCL America Inc; Franklin Lakes (NJ); On-site; USD 90,000 - 120,000; Full time

Job summary

HCL America Inc is seeking an experienced Onsite Lead to lead Design Verification, Sustaining Engineering, and New Product Development projects in Franklin Lakes, New Jersey. The ideal candidate will have a strong background in Mechanical Engineering with at least 5-7 years in the medical devices industry.

You will engage in all aspects of product development, oversee project management, and ensure compliance with regulatory standards. Strong communication skills and the ability to work collaboratively with stakeholders are essential.

Qualifications

• At least 5-7 years of experience in design and development of Medical products.
• Demonstrated experience in leading and managing a team.
• Experience with ISO requirements and FDA regulations is desirable.

Responsibilities

• Lead Design Verification, Sustaining Engineering & New Product Development projects.
• Ensure compliance with Good Documentation Practices.
• Provide training on GDP/GLP processes.

Skills

Excellent communication skills

Strong project management

Tolerance analysis of plastic components

Analytical and problem-solving skills

Fixture design & development

Statistical concepts

Proficient in Microsoft Office

Education

Bachelor’s or higher in Mechanical Engineering or related

Job description

HCL America Inc is seeking an experienced Onsite Lead to lead Design Verification, Sustaining Engineering, and New Product Development projects in Franklin Lakes, New Jersey. The ideal candidate will have a strong background in Mechanical Engineering with at least 5-7 years in the medical devices industry.

You will engage in all aspects of product development, oversee project management, and ensure compliance with regulatory standards. Strong communication skills and the ability to work collaboratively with stakeholders are essential.