Principal Engineer
Wilmington, MA
$110,000 - $150,000 DOE + 15% bonus
This is an incredible opportunity for you to join a leading Medical Device manufacturing company in Wilmington, MA. A challenging but extremely rewarding role with competitive pay and an excellent benefits package. Apply directly below if you have experience within Medical Device manufacturing.
Responsibilities:
- Effectively manage projects to meet scope, deadlines, and costs, ensuring compliance with company and international standards.
- Write and execute detailed validation protocols (FAT/IQ/OQ/PQ).
- Design and conduct research programs to evaluate and improve manufacturing processes, collaborating with vendors and operators.
- Ensure product and process quality through testing, establishing standards, and confirming manufacturing processes.
- Provide decision-making information by calculating production, labor, and material costs.
- Prepare reports on product and process trends.
- Solve product/process issues using Six Sigma, DoE, FMEA, and other methodologies.
- Conduct engineering aspects of contract reviews and perform cost/technical evaluations.
- Collaborate with Corporate IT on infrastructure projects.
- Manage stakeholder relationships and expectations, taking contingency actions as needed.
Requirements:
- BS in Engineering with 10+ years of experience, including 5-7 years in a medical device manufacturing role.
- Commitment to continuous improvement, with knowledge of Kaizen, 5S, value stream mapping, and Lean Six Sigma (certification preferred).
- Strong understanding of manufacturing processes, lean manufacturing principles, Six Sigma, and quality management systems.
- Proficiency in project management, including planning, scheduling, budgeting, and resource management.
- Strong analytical, problem-solving, and communication skills.
- Knowledge of quality management systems and regulatory requirements, including ISO standards.
