Lead Engineering Specialist
1 week ago
Lead Engineering Specialist
Location: Wilmington, MA
Compensation: $110,000 - $150,000 DOE + 15% bonus
This role presents a remarkable opportunity to become part of a prominent Medical Device manufacturing organization. It is a demanding yet highly fulfilling position that offers competitive remuneration and a comprehensive benefits package. Candidates with a background in Medical Device manufacturing are encouraged to consider this opportunity.
Key Responsibilities:
- Oversee project management to ensure alignment with scope, timelines, and budgetary constraints, while adhering to both company and international standards.
- Develop and implement detailed validation protocols (FAT/IQ/OQ/PQ).
- Design and execute research initiatives aimed at assessing and enhancing manufacturing processes, working closely with suppliers and production staff.
- Guarantee product and process quality through rigorous testing, establishing benchmarks, and validating manufacturing methodologies.
- Deliver analytical insights by calculating production, labor, and material expenditures.
- Compile reports detailing product and process performance trends.
- Address product/process challenges utilizing Six Sigma, Design of Experiments (DoE), Failure Mode and Effects Analysis (FMEA), and other analytical techniques.
- Conduct engineering evaluations during contract reviews and perform cost/technical assessments.
- Collaborate with Corporate IT on infrastructure development projects.
- Manage relationships and expectations of stakeholders, implementing contingency measures as necessary.
Qualifications:
- Bachelor's degree in Engineering with a minimum of 10 years of experience, including 5-7 years in a medical device manufacturing environment.
- Dedication to continuous improvement, with familiarity in Kaizen, 5S, value stream mapping, and Lean Six Sigma (certification preferred).
- In-depth knowledge of manufacturing processes, lean principles, Six Sigma methodologies, and quality management systems.
- Expertise in project management, encompassing planning, scheduling, budgeting, and resource allocation.
- Exceptional analytical, problem-solving, and communication abilities.
- Understanding of quality management systems and regulatory standards, including ISO requirements.
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