Process Improvement Engineer
2 weeks ago
Manufacturing Engineer Department:
Manufacturing Engineering
Employment Type:
Full Time
Overview:
The Manufacturing Engineer is responsible for designing and maintaining cost-effective, high-quality machining and manufacturing processes, tooling, and associated documentation for all produced components.
Key Responsibilities:
- Support the production floor to achieve business objectives while fostering collaboration among team members in a self-directed work environment.
- Collaborate with various departments, including Quality Assurance and Design Engineering, to address and resolve manufacturing challenges.
- Take ownership of all production operations, focusing on safety, scheduling, quality, and team development in designated areas.
- Develop and enhance manufacturing methods for both existing and new products.
- Identify and implement safe manufacturing processes that yield high-quality products efficiently.
- Contribute to the formulation of mid- and long-term plans that outline projects aimed at meeting business goals, emphasizing cost, product quality, and cycle time.
- Plan and execute process engineering activities for new product development and ongoing product support.
- Investigate and integrate new technologies to support growth initiatives.
- Assist supervisors and production staff in troubleshooting manufacturing process issues through root cause analysis and permanent corrective actions.
- Co-lead initiatives to maintain and enhance shop floor quality controls and best practices in collaboration with area team leaders.
- Pursue continuous improvement strategies for quality enhancement and cost reduction in assigned areas.
- Act as a change agent, guiding operations towards best-in-class performance benchmarks.
- Implement manufacturing processes and oversee equipment installation qualifications and process verification/validation studies.
- Create and manage controlled documentation for manufacturing processes.
- Utilize control processes within Exactech's Change Management System and Document Change Notifications to effect process changes.
- Develop timelines to ensure the timely completion of projects and contribute to the development of product project schedules.
- Understand and apply Quality System regulations along with relevant Federal and International standards.
- Provide project management leadership for the development of new products and the integration of vendor-supplied products or processes into Exactech's manufacturing operations.
Qualifications:
Education:
Bachelor's degree from an accredited institution or equivalent relevant work experience is required.
Experience:
1-3 years of experience in manufacturing and/or operations, preferably in the medical device sector. Familiarity with Good Manufacturing Practices (GMP) and Lean Manufacturing principles is advantageous.
Experience with FDA Part 820 Quality Systems Regulations is preferred, particularly within the medical device industry. Proficiency in the development and execution of Installation Qualification (IQ), Operational Qualification (OQ), and Performance Qualification (PQ) documentation is beneficial.
Knowledge of Siemens NX and Siemens Teamcenter is a plus, along with an understanding of geometric tolerancing and dimensioning (GD&T).
Ability to create programs and design tooling for component manufacturing based on prints or models.
Experience with medical device materials such as titanium, cobalt chrome, stainless steel, and UHMWPE is desirable.
Skills and Abilities:
Demonstrates behaviors that align with Exactech's culture and core values, including:
- Integrity: Exhibits honesty and strong moral principles.
- Accountability: Supports teammates and fulfills commitments.
- Innovation: Introduces new technologies and listens to challenges to develop impactful solutions.
- Passion: Driven to assist teammates, enhance processes, and ensure product quality.
Experience with tool and fixture design or improvement is beneficial. Familiarity with manufacturing in a regulated environment is essential. Ability to make data-driven decisions and utilize Six Sigma and Lean tools is required. Strong background in interpreting engineering drawings, specifications, and manufacturing processes is necessary. Excellent verbal and written communication skills are essential.
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