Job Description

JOB TITLE

Senior Manufacturing Engineer

DEPARTMENT

Manufacturing Engineer

JOB CODES

Contractor, 6 months

MAIN PURPOSE OF JOB AND OBJECTIVES

Please note this job description is not designed to cover or contain a comprehensive listing of activities, duties or responsibilities that are required of the employee for this job. Duties, responsibilities and activities may change at any time with or without notice.

1. Performs process, tool, and gauge development and implementation activities, implement cost reductions, develop process layouts, develop, and maintain manufacturing instructions and device history records, and execute process validation protocols, builds and reports

KEY DUTIES

1. Work with Manufacturing Engineer Manager and / or Manufacturing Director to determine projects and related tasks.
2. Manage and lead projects and tasks.
3. Manage Tooling System including preventive maintenance, calibrations, and equipment records (if applicable)
4. Support & develop new processes that increase productivity and reduce cost.
5. Implement cost reductions via materials or manufacturing time.
6. Implement new process and issue process validation protocols and reports.
7. Develop fixtures, gigs, and gages.
8. Utilize Lean Manufacturing principles to increase productivity / throughput, reduce cost, and /or eliminate waste.
9. Document methods for manufacturing and inspection
10. Log evaluations into Engineering Notebooks
11. Perform Installation Qualification, Operational qualification, Test method validations, Computer/ software validation and Performance qualification as part of Manufacturing or equipment validation activities.
12. Perform time studies, process mapping, engineering testing, and DOE.
13. Utilize statistics to evaluate, justify, and support experiments, analysis, and validations.
14. Work with Mfg. Supervisor to analyze Manufacturing data, lead improvement projects that come from this analysis and group leader for Projects.
15. Available to support as a Manufacturing Engineer to support manufacturing Production overtime if it is required.
16. Develop, document (using AutoCAD / SolidWorks), and implement fixtures, jigs, tools, and gages.
17. Initiate process, design, and documentation changes through the change management process.
18. Perform Root Cause Investigations, develop and implement solutions.
19. Work with Mfg. Supervisor to analyze Manufacturing data and lead improvement projects that come from this analysis. (if applicable)

COMPANY

REQUIREMENTS

1. Must work within requirements of company handbook and policy statements

Note: Company Handbook, Policy Statement and Authorization of Limits do not form part of the quality system

QUALITY

REQUIREMENTS

1. Maintain awareness of the relevance and importance of activities performed and how they contribute to the achievement of quality objectives
2. Work within the QMS at all times, ensure accurate completion of records and highlight issues to immediate supervisor any issues affecting quality
3. Responsible to ensure facility, processes and documentation remain in a state of audit readiness at all times

EH&S REQUIREMENTS

1. Take care of your own health and safety and that of others who may
2. be affected by your actions
3. Work co-operatively to highlight issues affecting Environmental Health and Safety

1. QUALIFICATIONS & EXPERIENCE

1. Applies business understanding.
2. Technical leadership in an area of engineering core competency
3. Effective application of cross-functional and external resources to engineering activities
4. Subject matter expertise in QMS and design control requirements in area of engineering focus
5. Communicates effectively.
6. Effective cross-functional communication leadership skills
7. Preparation and delivery of effective technical presentations to senior management.
8. Developing organizational "presence" in communications
9. Demonstrates customer focus.
10. Provides functional leadership in applying understanding of engineering responsibilities to internal/external customers being supported.
11. Develop self and others.
12. Demonstrated understanding of engineering role and application of engineering skills with developing subject matter expertise
13. Developing mentor to lower position engineers
14. Drives improvement, innovation, and changes
15. Demonstrated innovative thinking and complex problem solving on product and process.
16. Embraces organizational change and leads improvement opportunities.
17. Takes accountability for results.
18. Completes individual and leads project teamwork activities as assigned demonstrating ability to effectively manage overall productivity and deliver strong technical results.
19. Bachelor’s degree in engineering/science and a minimum of (8) eight years’ experience in the medical device industry or (5) five years in the medical device industry with a master’s degree in engineering/science
20. Project management experience in the medical device industry
21. Hands-on knowledge of electronics, motion control, plastics, metrology, metallurgy, and manufacturing processes
22. Experience with polymers, medical grade metals and medical packaging
23. Ability to organize and conduct experiments independently.
24. Hands on abilities to engineer tooling, processes, and equipment.
25. Excellent written and verbal communication skills (English)
26. Hands on experience building prototypes, tooling, and fixtures.
27. Ability to analyze and solve technical problems.
28. Proficient in software applications

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