Manufacturing Engineer

Essential Functions

• Develop manufacturing processes that can meet all internal and external requirements.
• Specify, purchase, implement, and provide ongoing support for new manufacturing equipment.
• Responsible for creating Process Control Plans.
• Provide technical expertise and troubleshooting assistance to production teams to resolve manufacturing issues, minimize downtime, and ensure smooth operations.
• Identify and act upon opportunities for continuous improvement to manufacturing.
• Contribute, as core team members, to process risk analysis activities.
• Responsible for ensuring continuous adequacy of test equipment and test methods through proper validation, measurement systems analysis, and Gage Repeatability and Reproducibility testing.
• Write process deviation and rework instructions, as required.
• Create and maintain accurate and up-to-date equipment specifications and other manufacturing processes documentation.
• Support fixture and tool development to ensure that the needs of production are reflected in designs and specifications.
• Provide technical support and expertise for manufacturing equipment validation activities.
• Ensure compliance with safety regulations, industry standards, and good practices/ergonomics.

Additional Responsibilities

• Must be able to manage multiple projects simultaneously.
• Maintains accurate and compliant documentation to meet company, and regulatory expectations.
• Provides direction and helps prioritize Technician tasks.
• Accomplishes all other duties and tasks as appropriately assigned or requested.

Education & Experience

• Level I: BS Engineering or Engineering Technology. 0-2 years of relevant work experience in Manufacturing Engineering within a regulated industry. Experience in Medical Device or Pharma preferred.
• Level II: BS Engineering or Engineering Technology. 2 to 5 years of relevant work experience in Manufacturing Engineering or MS with 1 to 5 years of experience within a regulated industry. Experience in Medical Device or Pharma preferred.
• Level III: BS Engineering or Engineering Technology. 5 to 7 years of relevant work experience in Manufacturing Engineering or MS with 1 to 5 years of experience within a regulated industry. 3-5 or more years of Engineering experience in medical device or other regulated industry acceptable with Master’s Degree. Experience in Medical Device or Pharma preferred.
• Senior: BS Engineering or Engineering Technology. 7-12 years of relevant work experience or MS with 6+ years of experience in Manufacturing Engineering within a regulated industry. 5-7 or more years of Engineering experience in medical device or other regulated industry acceptable with Master’s Degree. Experience in Medical Device or Pharma required.

Knowledge, Skills & Abilities

• Level I: Proficient in MS Office (Word, Excel, PowerPoint), Minitab or any other SPC software.
• Capable of written and verbal presentation of technical concepts to leadership (Intermediate Proficiency).
• Mechanical knowledge and aptitude to analyze and trouble shoot abnormal operation conditions on equipment, devices, fixtures, among others.
• Familiar with manufacturing efficiency strategies such as Lean, Six Sigma, 5S, Value Stream mapping, etc.
• Strong problem solving and analytical skills.
• Knowledge in Design of Experiments and statistical analysis tools, and statistical process control.
• Familiar with Design for Manufacturing, FMEA, Production Readiness, and Cell Layout.
• Understanding of ergonomics as related to repetitive stress injuries.
• Intermediate Writing skills to compose reports and documents for efficient information transfer.
• Familiar with 3D CAD Design Software.
• Problem solving and decision-making skills.
• Ability to work independently and with a team.
• Attention to detail.
• Create Project Plans and organize resources to ensure project milestones are met within expectations of timeline and product quality.
• Familiarity with working from ISO to other internationally recognized standards.
• Familiarity in GD&T.
• Knowledge of root cause analysis and problem-solving techniques.
• Knowledge of Engineering and Manufacturing best practices.
• Level II, III: Proficient with manufacturing efficiency strategies such as Lean, Six Sigma, 5S, Value Stream mapping, Takt time and its drivers and support tools, among others.
• Proficient at Design for Manufacturing, FMEA, Production Readiness, and Cell Layout.
• Expert writing skills to compose reports and documents for efficient information transfer.
• Expert PC skills with Engineering and office related software systems.
• Experience using 3D CAD Design Software.
• Proficient in Problem solving and decision-making skills.
• Knowledge and understanding of FDA QSR and ISO 13485, 14971.
• Proficient with Design of Experimentation methodology and statistical analysis tools.
• Work independently - self-motivated.
• Proficiency in GD&T.
• Excellent Organization, time management, and project management skills.
• All knowledge, skills, and abilities as listed for level I.
• Senior: Expertise in problem solving and decision-making skills are necessary and ability to work independently and with a team.
• Expertise with Creating Project Plans and organizes resources to ensure project milestones are met within expectations of timeline, quality, and budget.
• Mentor/Train less experienced personnel on manufacturing Engineering methodology.
• All knowledge, skills, and abilities as listed for levels I, II, and III.