Position Overview :
The Manufacturing Engineer serves as a technical leader responsible for managing and overseeing manufacturing engineering activities while ensuring compliance with quality systems, regulatory requirements, and industry standards. This role involves initiating and leading continuous improvement programs, driving technical communications with customers, and optimizing departmental processes.
Key Responsibilities :
- Lead and manage manufacturing engineering activities to support production and product quality.
- Ensure compliance with quality systems, including regulatory standards such as 21 CFR 820.30 and ISO 13485.
- Drive continuous improvement initiatives for assigned product accounts, as well as departmental processes and procedures.
- Serve as a primary technical point of contact for customers, ensuring effective communication and collaboration.
- Analyze production processes to identify inefficiencies and implement improvements.
- Support new product introductions (NPI) and ensure smooth transitions to manufacturing.
- Develop and maintain documentation, including work instructions, process flows, and validation protocols.
- Collaborate with cross-functional teams to resolve technical challenges and meet project objectives.
Qualifications :
- Bachelor’s degree in Manufacturing Engineering, Mechanical Engineering, or a related field.
- 5+ years of experience in manufacturing engineering, preferably in a regulated industry.
- Strong knowledge of quality systems, including ISO 13485 and 21 CFR 820.30.
- Proven experience with continuous improvement methodologies (e.g., Lean, Six Sigma).
- Excellent problem-solving and analytical skills.
- Strong communication and leadership abilities, with experience in customer-facing roles.
- Proficiency in technical documentation and regulatory compliance.
Preferred Skills :
- Experience in medical device manufacturing or other highly regulated industries.
- Familiarity with process validation and qualification protocols.
- Certification in Lean Six Sigma or related quality improvement methodologies.
Salary info:
$38 - $50 / hr