Job Title: Manufacturing Engineer

Job Description

We are seeking a dedicated Manufacturing Engineer to analyze mechanical designs, including technical drawings and associated measurement systems. This role involves collaboration with Design Engineering and Manufacturing teams to integrate Design for Manufacture & Assembly and Design to Cost perspectives during verification. You will drive capital equipment requests and qualifications, conduct labor and process studies, lead yield improvements, and support manufacturing in resolving technical problems while leading cost reduction initiatives. You will also lead efforts to perform root cause analyses, resolve and implement product fixes, modifications, and design enhancements. Additionally, you will ensure process and design changes are documented and adhere to industry quality standards, authoring and updating technical and process documentation as required.

Responsibilities

• Analyze mechanical designs, including technical drawings and associated measurement systems.
• Work with Design Engineering and Manufacturing teams to integrate a Design for Manufacture & Assembly and Design to Cost perspective during verification.
• Drive capital equipment requests and qualification processes.
• Conduct labor and process studies and lead yield improvements to reduce variability.
• Support manufacturing in resolving technical problems and lead cost reduction initiatives.
• Lead efforts to perform root cause analyses and implement product fixes, modifications, and design enhancements.
• Ensure process and design changes are documented and adhere to industry quality standards.
• Author and update technical and process documentation as required.
• Analyze labor data against existing standards using provided templates, identify root causes, and propose corrective actions where large variances exist.
• Develop and maintain positive rapport and working relationships with other personnel across the organization to support initiatives for product improvements and enhancements.
• Perform other duties as assigned.

Essential Skills

• 5+ years of manufacturing engineering experience.
• In-depth knowledge of creation of 2D and 3D drawings and related Bill of Materials.
• Creation of process flow diagrams and process control plans.
• Authoring PFMEA’s.
• Project management and strong organizational and time management skills.
• Detail-oriented and deadline-oriented.
• High initiative with the ability to work independently and problem-solve with minimal supervision.
• Strong work ethic and ability to communicate effectively both verbally and in writing.
• Strong interpersonal skills to interact with staff at all levels within and external to the organization.

Additional Skills & Qualifications

• Single Use Consumable design and development experience.
• Biotech device development experience.
• Process characterization experience applying Design of Experiments to optimize manufacturing processes.
• Statistical Process Control (SPC) experience.
• Experience with Lean manufacturing, Six Sigma, Solidworks, and tooling.
• Experience with medical device processes, including IQ/OQ/PQ, BOM, and process flow diagrams.

Work Environment

The work environment involves interaction with key personnel both internally and with external partners. You will be expected to develop and maintain positive rapport and working relationships across the organization. The role requires a strong work ethic, effective communication skills, and the ability to work independently with minimal supervision. The environment encourages collaboration and initiative to drive product improvements and enhancements.