Technical Lead

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

Job Description

Onsite Lead plans, leads, reviews and front-ends Design Verification, Sustaining Engineering and New Product Development projects as a technical contributor cum project leader and engages in all aspects of product development.

Education

• Bachelor’s or higher education in Mechanical Engineering or related engineering/technology streams (Manufacturing / Mechatronics / Polymer Science / BioMedical)

Experience

• At least 5-7 years of working experience in design and development of Medical products, preferably in a regulated industry Medical Device.

Core Skills

• MUST have excellent communication skills (verbal, written, presentation & articulation), appropriate for varying levels of stakeholders.
• Strong project management background in R&D or manufacturing environment.
• Strong experience in tolerance analysis of plastic components in molding and assembly.
• Excellent analytical and problem-solving skills, as well as a good background in product development/manufacturing process specifically in high volume molding & assembly operations.
• Experience in leading and managing a small group of engineers and technicians.
• Demonstrated ability to effectively, critical thinking and clearly communicate concepts, ideas, and knowledge to other individuals and teams.
• Experience in fixture design & development and test method development, implementation and validation.
• Desirable experience with ISO requirements and GMP guidelines, FDA regulations, medical device design control, and manufacturing scale up processes.
• Good on statistical concepts such as in measurement system analysis and design verification.
• Proficient in Microsoft Office products with an emphasis on MS projects, Excel and Word.

Responsibilities

1. Leads the Design Verification, Sustaining Engineering & New Product Development projects and applies the best engineering practices and tools.
2. Demonstrates excellent project management, contributes on projects as the R&D member, carrying out assigned responsibilities in a timely, diligent, safe and professional manner.
3. Develops and maintains good rapport with business leaders, other internal functions, technical consultants, outside vendors, and other stakeholders to accomplish project objectives and be a strong team-player.
4. Reviews the deliverables to ensure completeness, accuracy, and appropriateness of the design output/test executed and ensure its compliance with Good Documentation Practices.
5. Provides training to the team on GDP/GLP, IQ/OQ process, Calibration & Preventive maintenance activities and ensures the quality of deliverables.
6. Involves in the review/creation of DV Protocols and provides valuable inputs regarding test equipment selection, capability/accuracy, sample size optimization, acceptance criteria definition, etc.
7. Conducts Weekly Status Review Meeting with stakeholders, shares the progress of various projects supported/led, keeps a track on the self-utilization.
8. Promptly follow-up with the parties concerned for review/approval/signatures of project artifacts (including Memos, MSA, DV Protocol & Reports, IQ/OQ Protocols & Reports, etc).
9. Quality System accountability: Maintains all relevant Protocols, Procedures, Reports and Records to ensure strict compliance of R&D functional operation to meet the Quality System requirements.
10. Supports the organization’s intellectual property strategy by documenting data and independent, unique and patentable ideas that result from experimentations.
11. Performs any other tasks (like Sustaining Engineering / New Product Development activities), as assigned.

Qualifications

• Bachelor’s or higher education in Mechanical Engineering or related engineering/technology streams (Manufacturing / Mechatronics / Polymer Science / BioMedical)