Quality/manufacturing Engineer

We are seeking a skilled and experienced Quality Engineer with a strong background in machining and manufacturing for the Medical Device industry. The ideal candidate will be responsible for ensuring the quality and reliability of our products, as well as driving continuous improvement initiatives in our manufacturing processes.

Key Responsibilities:

- Work on New Product Development (NPD) projects, collaborating with cross-functional teams to ensure quality and manufacturability of new products.

- Attend meetings and collaborate with the Machine Shop and Assembly teams to optimize part numbers and production processes.

- Oversee the machining and gauging of parts, working closely with our machine shop and assembly building to ensure high-quality production.

- Collaborate with suppliers to address and troubleshoot areas of concern, driving quality improvements and cost efficiencies.

- Work closely with the Design for Manufacturing (DFM) team to provide input on manufacturability and identify opportunities for process enhancements.

- Lead or oversee the onsite fixturing of parts, contributing to the development and implementation of efficient manufacturing processes. - Provide on-site support and expertise to ensure compliance with quality standards and best practices.

Qualifications:

- Bachelor’s degree in Mechanical Engineering, Manufacturing Engineering, or a related field.

- Minimum of X years of experience in a manufacturing environment, with a focus on machining and quality engineering in the Medical Device industry.

- Strong knowledge of machining processes, quality control methods, and manufacturing best practices.

- Experience with New Product Development (NPD) projects and working in a regulated industry (e.g., FDA regulations, ISO standards).

- Excellent problem-solving skills and the ability to effectively collaborate with cross-functional teams.

- Strong communication and interpersonal skills, with a focus on building strong relationships with internal and external stakeholders.