BioTalent Ltd
Sr. Project Engineer (NPI/Sustaining)
BioTalent Ltd, Westlake Village, California, United States, 91361
Position: R&D Sustaining Engineer
Overview
The R&D Sustaining Engineer will lead projects and provide technical expertise to ensure the continued reliability, compliance, and cost-effectiveness of existing medical device products. This role plays a vital part in supporting products throughout their lifecycle by resolving manufacturing challenges, implementing design improvements, and driving continuous improvement initiatives. The engineer will work collaboratively with cross-functional teams—including Manufacturing, Quality, Supply Chain, and Regulatory Affairs—to maintain product quality and ensure compliance with all applicable standards.
Key Responsibilities Project Leadership
Lead small to mid-sized sustaining engineering projects focused on product and process improvements, cost reduction, and component obsolescence management.
Develop and manage project plans, schedules, and deliverables to ensure timely and successful completion.
Manufacturing Support
Serve as the primary R&D liaison for manufacturing and production support.
Partner with Manufacturing Engineering to troubleshoot product and process issues, perform root cause analyses, and implement effective corrective and preventive actions (CAPAs).
Design & Process Changes
Plan, coordinate, and execute sustaining engineering activities, including:
Project scheduling and documentation updates
Quality and regulatory documentation
Labeling and Instructions for Use (IFU) updates
Design requirements and specification trace matrices
Real-time aging retention and testing
Verification and Validation (V&V) testing, including protocol and report generation
Returned product evaluations and competitive product benchmarking
Change orders, technical reviews, and implementation support
Qualifications Education
Bachelor’s degree in
Biomedical, Mechanical, Electrical Engineering , or a related technical discipline.
Experience
Minimum
4 years
of experience in a regulated industry, with a focus on
medical device product development or sustaining engineering .
Experience with
Class II or Class III medical devices
preferred.
Strong background in
medical device component design, material processing, and manufacturing .
Comprehensive understanding of
ISO, GMP, and FDA regulations
related to medical device design and development.
Skills & Competencies
Strong analytical and problem-solving skills, with a solid understanding of
design control processes, risk management, and process/design validation .
Demonstrated
project management
expertise.
Experience with
lean manufacturing
and
continuous improvement methodologies .
Excellent verbal, written, and presentation communication skills.
Proficient in
Microsoft Office
and
MS Project .
Hands-on experience with
SolidWorks .
Working knowledge of
medical device sterilization techniques
and
regulatory requirements .
Ability to adapt and take on additional responsibilities to support evolving business objectives.
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Key Responsibilities Project Leadership
Lead small to mid-sized sustaining engineering projects focused on product and process improvements, cost reduction, and component obsolescence management.
Develop and manage project plans, schedules, and deliverables to ensure timely and successful completion.
Manufacturing Support
Serve as the primary R&D liaison for manufacturing and production support.
Partner with Manufacturing Engineering to troubleshoot product and process issues, perform root cause analyses, and implement effective corrective and preventive actions (CAPAs).
Design & Process Changes
Plan, coordinate, and execute sustaining engineering activities, including:
Project scheduling and documentation updates
Quality and regulatory documentation
Labeling and Instructions for Use (IFU) updates
Design requirements and specification trace matrices
Real-time aging retention and testing
Verification and Validation (V&V) testing, including protocol and report generation
Returned product evaluations and competitive product benchmarking
Change orders, technical reviews, and implementation support
Qualifications Education
Bachelor’s degree in
Biomedical, Mechanical, Electrical Engineering , or a related technical discipline.
Experience
Minimum
4 years
of experience in a regulated industry, with a focus on
medical device product development or sustaining engineering .
Experience with
Class II or Class III medical devices
preferred.
Strong background in
medical device component design, material processing, and manufacturing .
Comprehensive understanding of
ISO, GMP, and FDA regulations
related to medical device design and development.
Skills & Competencies
Strong analytical and problem-solving skills, with a solid understanding of
design control processes, risk management, and process/design validation .
Demonstrated
project management
expertise.
Experience with
lean manufacturing
and
continuous improvement methodologies .
Excellent verbal, written, and presentation communication skills.
Proficient in
Microsoft Office
and
MS Project .
Hands-on experience with
SolidWorks .
Working knowledge of
medical device sterilization techniques
and
regulatory requirements .
Ability to adapt and take on additional responsibilities to support evolving business objectives.
#J-18808-Ljbffr