Onsite Lead Engineer

TechDigital Group; Sandy (UT); On-site; USD 80,000 - 100,000; Full time

Job summary

A leading engineering firm in Sandy, Utah, seeks an Onsite Engineer to lead Design Verification and New Product Development projects. Candidates should have a Bachelor's in Mechanical Engineering and 5–7 years of experience in product development, specifically in medical devices. Strong project management and communication skills are essential for success in this role, which offers opportunities for continuous improvement and cross-functional collaboration.

Qualifications

• 5–7 years of relevant experience in product development and design.
• 2–3 years of experience specifically in medical devices/products.
• Proven track record in leading cross-functional teams.

Responsibilities

• Leads Design Verification and New Product Development projects.
• Maintains compliance with Quality System requirements.
• Provides training on GDP/GLP and project management.

Skills

Project management

Communication skills

Leadership capabilities

Cross-functional team coordination

Education

Bachelor's degree in Mechanical Engineering

Job description

Onsite Engineer 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.

Key Responsibilities

• Leads the Design Verification, Sustaining Engineering & New Product Development projects and applies the best engineering practices and tools.
• Demonstrates good project management, contributes on projects as the R&D member, carrying out assigned responsibilities in a timely, diligent, safe and professional manner.
• 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.
• Reviews the deliverables to ensure completeness, accuracy and appropriateness of the design output / test executed and ensure its compliance to Good Documentation Practices.
• Provides training to the team on GDP/GLP, IQ/OQ process, Calibration & Preventive maintenance activities and ensures the quality of deliverables.
• Involves in the review / creation of DV Protocols and provides valuable inputs in terms of test equipment selection, capability / accuracy, sample size optimization, acceptance criteria definition, etc.
• Conducts Weekly Status Review Meeting with stakeholders, shares the progress of various projects supported / led, keeps a track on the self-utilization.
• Seeks for continuous improvement through value propositions (e.g. test method optimization) by identification of possible opportunities for time reduction / cost reduction / quality improvement.
• Promptly follows-up with stakeholders for review / approval / signatures of project artifacts (including Memos, MSA, DV Protocol & Reports, IQ/OQ Protocols & Reports etc).
• 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.
• Provides cross-functional coordination based on project needs.
• Supports the organization's intellectual property strategy by documenting data and independent, unique and patentable ideas that result from experimentations.
• Performs any other tasks (like Sustaining Engineering / New Product Development activities), as assigned.

Education

Bachelor's or higher education in Mechanical Engineering or related engineering / technology streams (Mechatronics / Polymer science / BioMedical / Plastics, etc...)

Experience

• 5–7 years of relevant experience in product development and design.
• 2–3 years of experience specifically in medical devices/products.
• Proven track record in leading cross-functional teams through QMS and regulatory product development processes.
• Demonstrated success in project or program management.
• Strong communication and leadership capabilities.
• Ability to influence stakeholders and work across functions.
• Experience managing technical projects and cross-functional teams.
• Familiarity with product development and compliance processes.