Manufacturing Engineer III or Sr. Engineer
Manufacturing Engineer II or Senior
MANUFACTURING ENGINEER ESSENTIAL DUTIES AND RESPONSIBILITIES:
• Extensive experience with equipment installation and validation activities (URS, FDS, IQ, OQ, PQ, and VRA) is a must.
• Experience with cleaning validations (IQ, OQ, PQ) is a must.
• Working knowledge of finishing process including bead blasting process is a must.
• Develops, implements and maintains methods, operation sequence and processes in the manufacture or fabrication of parts, components, sub-assemblies and final assemblies. Interfaces with design engineering in coordinating the release of new products. Estimates manufacturing cost, determines time standards, and makes recommendations for tooling and process requirements of new or existing product lines. Maintains records and reporting systems for coordination of manufacturing operations.
• GD&T knowledge/experience
• Experience/knowledge with process characterization, analysis, control and validation utilizing statistical tools (Six Sigma methodologies and experience)
•Design experience – can be product, fixturing, gauging, tooling, etc.
Data analysis & critical thinking skills
• Materials experience/knowledge with manufacturing using (all or some): Titanium, Cobalt Chrome, Stainless Steels, medical grade plastics, etc. Process experience/knowledge with (all or some): machining of metals
• Experience with mass finishing process (barrel finishing)
• Experience with capital projects including financial justifications, monitoring spend.
• Lean manufacturing experience
• Experience leading continuous improvement projects
Nice to Have
• Advanced Degree in Science or Engineering
• Demonstrated proficiency in development of product requirements into machine User Requirement • Specifications (URS) that mitigate patient risk through pFMEA traceable URS risk mitigations
• Knowledgeable in the understanding and development of validation plans and reports
• Strong verbal and written communication and presentation skills
• Experience in developing equipment for use in a clean room environment
Other Job Functions:
• Experience with Process Maps, pFMEA, MSA and/or other risk analysis tools
• Makes credible decisions based on facts, appropriate risk analysis and sound judgment. Is prudent with company resources.
• Makes decisions that take customer interests into account. Strives to fine mutual solutions.
• Demonstrates courage in bringing forward new ideas and seeing them through to completion.
• Has a strong Drive for Results and acts with appropriate sense of urgency.
• Respects and values differences; takes advantage of differences to optimize results. Demonstrates empathy and respect.
• Thinking critically to penetrate complex problems and expanding possibilities by making fresh connections. Enjoying experimentation, being curious and effectively dealing with the discomfort of change.
• Ability to engage and be present. Empathetic listener.
• Self-awareness – the ability to know one's own emotions, strengths, weaknesses, drives, values and goals and recognize their impact on others. Self-regulation – controlling or redirecting one's disruptive emotions and impulses and adapting to changing circumstances.
• Ability to make impactful Power Point presentations
• Performs other duties as assigned by the Manufacturing Engineering Project Manager.
EDUCATION AND/OR EXPERIENCE:
BS in Engineering, Science, or related field + 5 Years – Level II
BS /MS in Engineering, Science, or related field + 7+ years’ experience – Senior ME
The physical demands described here are representative of those that must be met by an employee to successfully perform the essential functions of this job. Reasonable accommodations may be made to enable individuals with disabilities to perform essential functions.
Requires standing/walking 1/3-2/3 of the time, sitting 1/3-2/3 of the time, talking or hearing 2/3 or more of the time.
Requires reaching with hands and arms 2/3 or more of the time.
Requires lifting up to 25 pounds up to 1/3 of the time.
Requires close, distance, color, and peripheral vision; depth perception and the ability to adjust focus.