Sr. Manufacturing Engineer

ZipRecruiter; Gainesville (FL); On-site; USD 80,000 - 110,000; Full time

Job summary

A leading company in the medical device industry seeks an experienced Manufacturing Engineer. The role involves creating machining processes, mentoring junior engineers, and leading projects to ensure high-quality production. Suitable candidates should have a strong background in CNC and CAD/CAM processes, with at least 7 years of relevant experience.

Qualifications

• 7+ years creating machining processes in the medical device industry.
• Strong CNC machining and CAD/CAM experience.
• Experience with medical device materials and interpretation of engineering drawings.

Responsibilities

• Develop and maintain manufacturing processes and tooling.
• Supervise junior team members and mentor
• Support projects and solve manufacturing issues cross-functionally.

Skills

CNC machining

Programming

Data-driven decision making

Lean Manufacturing

Good Manufacturing Practices

Geometric dimensioning and tolerancing

Communication

Education

Bachelor’s Degree

Tools

Siemens NX

Teamcenter

Job description

Job Description

Create and maintain manufacturing and machining processes, tooling, and supporting documentation for all parts produced. Provide support and leadership for new products as well as in-sourcing products as identified by manufacturing leadership. Assist in developing manufacturing engineers and associate manufacturing engineers through mentoring and leadership.

Key Responsibilities

• Support shop floor to deliver business results while encouraging input from area personnel in a self-directed workforce environment. Interact cross-functionally with departments such as Quality Assurance and Design Engineering to solve manufacturing problems.
• Develop tooling and processes for machining of production items.
• Implement total machining process and conduct Verification/Validation studies.
• Develop Multiaxis CNC programs from Siemens NX solid models for prototypes and new products per approved engineering projects.
• Provide manufacturing method development and improvement for current and new products.
• Determine safe manufacturing processes that produce quality products efficiently.
• Participate in developing mid and long-term plans supporting business objectives with a focus on cost, quality, and cycle time.
• Troubleshoot machining processes and adjust CNC programs as needed.
• Create and maintain controlled documentation for manufacturing processes.
• Assist in developing manufacturing machinists, training them on new processes and methods.
• Mentor and supervise junior team members' performance and development.
• Identify and execute manufacturing process improvements.
• Support other departments like Quality Assurance and Design Engineering in solving manufacturing issues.
• Create and document machining work instructions and perform process verifications.
• Develop project schedules ensuring timely completion and contribute to product project schedules.
• Implement process changes using control processes within Exactech’s Change Management System and Document Change Notifications.
• Apply Quality System regulations and relevant standards.
• Support other projects, tasks, employees, teams, and sales personnel as necessary.
• Provide project management leadership for new product development and integration of vendor-supplied products or processes into manufacturing.

Skills, Knowledge, and Expertise

Education: Bachelor’s Degree or equivalent relevant work experience.

Experience:

• At least 7 years creating machining processes from CAD models and prints, preferably in the medical device industry.
• Strong CNC machining and programming experience.
• Minimum of 7 years CAD/CAM experience, with Siemens NX expertise.
• Successfully completed at least two major and three minor projects involving manufacturing development.
• Minimum of 5 years experience with Good Manufacturing Practices & Lean Manufacturing in the medical device industry.
• Ability to make data-driven decisions using Six Sigma and Lean tools.
• Experience in developing and executing IQs, OQs, and PQs, and writing validation/verification plans.
• Knowledge of Siemens NX and Teamcenter is a plus.
• Thorough understanding of geometric dimensioning and tolerancing.
• Experience with medical device materials such as titanium, cobalt chrome, stainless steel, and UHMWPE.
• Strong interpretation skills for engineering drawings and specifications.

Functional/Technical Skills and Abilities

• Exhibits behaviors aligned with Exactech’s culture and values.
• Excellent verbal and written communication skills.
• Ability to work independently and as part of a team.
• Knowledge of ISO and quality procedures.