Sr. Engineer, Manufacturing

Job Summary

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

Job Details/Responsibilities

• Work with Manufacturing Engineer Manager and / or Manufacturing Director to determine projects and related tasks.
• Manage and lead projects and tasks.
• Prepare, analyze, and present data at monthly NCR and Management Review meetings (if applicable)
• Manage Tooling System including preventive maintenance, calibrations, and equipment records (if applicable)
• Manage duties of manufacturing Technician, Intern and Manufacturing Engineers including workload and personal issues (if applicable).
• Refine manufacturing processes and flow.
• Support & develop new processes that increase productivity and reduce cost.
• Implement cost reductions via materials or manufacturing time.
• Implement new process and issue process validation protocols and reports.
• Develop fixtures, gigs, and gages.
• Investigate and provide engineering support to Manufacturing processes, SPC, and non-conforming material (NCR)
• Complete investigation, improvements, documentation of preventative and corrective actions (CAPAs)
• Utilize Lean Manufacturing principles to increase productivity / throughput, reduce cost, and /or eliminate waste.
• Document methods for manufacturing and inspection
• Work with Research & Development and Process development to develop and transfer new manufacturing process designs to manufacturing.
• Log evaluations into Engineering Notebooks
• Perform Installation Qualification, Operational qualification, Test method validations, Computer/ software validation and Performance qualification as part of Manufacturing or equipment validation activities.
• Perform time studies, process mapping, engineering testing, and DOE.
• Utilize statistics to evaluate, justify, and support experiments, analysis, and validations.
• Work with Mfg. Supervisor to analyze Manufacturing data, lead improvement projects that come from this analysis and group leader for Projects.
• Available to support as a Manufacturing Engineer to support manufacturing Production overtime if it is required.
• Develop, document (using AutoCAD / SolidWorks), and implement fixtures, jigs, tools, and gages.
• Initiate process, design, and documentation changes through the change management process.
• Perform Root Cause Investigations, develop and implement solutions.
• Work with Mfg. Supervisor to analyze Manufacturing data and lead improvement projects that come from this analysis. (if applicable)

Job Responsibilities (continued)

Working Conditions/Physical Requirements

Quality requirements:

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

EH&S requirements:

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

Knowledge, Skills and Abilities (KSA)

Applies business understanding.

• Technical leadership in an area of engineering core competency
• Effective application of cross-functional and external resources to engineering activities
• Subject matter expertise in QMS and design control requirements in area of engineering focus

Communicates effectively

• Effective cross-functional communication leadership skills 
• Preparation and delivery of effective technical presentations to senior management.  
• Developing organizational "presence" in communications

Demonstrates customer focus

• Provides functional leadership in applying understanding of engineering responsibilities to internal/external customers being supported.

Develop self and others

• Demonstrated understanding of engineering role and application of engineering skills with developing subject matter expertise 
• Developing mentor to lower position engineers

Drives improvement, innovation, and changes

• Demonstrated innovative thinking and complex problem solving on product and process.
• Embraces organizational change and leads improvement opportunities.

Takes accountability for results

• Completes individual and leads project teamwork activities as assigned demonstrating ability to effectively manage overall productivity and deliver strong technical results.

Qualifications/ Background Experiences

• 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 
• Project management experience in the medical device industry
• Hands-on knowledge of electronics, motion control, plastics, metrology, metallurgy, and manufacturing processes
• If acting as Laser Safety Office (LSO) - Certification of Laser & X-ray safety
• Experience with polymers, medical grade metals and medical packaging
• Ability to organize and conduct experiments independently.
• Hands on abilities to engineer tooling, processes, and equipment.
• Excellent written and verbal communication skills (English)
• Hands on experience building prototypes, tooling, and fixtures.
• Ability to analyse and solve technical problems.
• Proficient in software applications