Summary:

The Manufacturing Engineer completes assigned projects as required for Production. Responsibilities include but are not limited to inspection, production, equipment introduction, preventative maintenance, and process validation. 

The position reports directly to the Head of Manufacturing Transfer

Key Accountabilities:

Production Sustaining Engineering- 40%
Accountable to support engineering tasks derived from transferred production products related to product performance, product safety, product cost, product regulatory, and product quality requirements.
 
NPI Manufacturing Engineering Support – 40%
Accountable to support engineering tasks derived from Client product manufacturing process efficiency, process cost, and process quality requirements are achieved per project schedule and budget.
 
Team Member Coaching and Support- 10%  
Accountable to coach functional team members and less experienced associates pertaining to process controls, measurement methods, failure investigations and trend analysis.
 
Continuous Improvement (Optimize and Innovate Culture)- 10%
Accountable to optimize and innovate through leadership influence, engineering methods and functional group processes.

NPI Manufacturing Engineering Support – 40%

• Develop and perform validations protocols and reports (IQ, OQ, PQ) in association with production process, equipment and facility needs.
• Help develop processes and procedures for new product lines including DOE.
• Develop device master records (DMR) for new Client products.
• Provide DFM/DFA support during development of NPI products.
• Support management of new and existing equipment files including facilitating calibrations, preventative maintenance, equipment improvements, and procurement.
• Proactively report project activities, issues, and schedule to management.
• Collect, analyze, and interpret manufacturing data to make sound decisions which impact production, personnel, and processes.
• Ensure production equipment is evaluated for safe operation and proper safety measures are in place as needed.

Production Sustaining Engineering- 40%

• Support company goals and objectives, policies and procedures that comply with worldwide regulations.
• Support Prospect ERP system which includes receiving inspection methods, Work order generation and management, labeling, warehousing, and personnel training.
• Correct quality issues which may include meeting with management to develop quality or process improvement plans.
• Review non-conforming product, assess condition and viable rework, and prepare rework instructions.
• Become SME on individual production lines providing technical and performance support while also giving regular updates and metrics report outs to management and clients.
• Provide guidance and training to production operators as needed in support of ongoing production while incorporating their feedback regarding process improvements.
• Complete other engineering duties as assigned and provide support for other departments, as necessary.
• Help solve production-related problems and document solutions for existing product lines.
• Improve efficiencies of existing Client product lines.

Team Member Coaching and Support- 10%  

• Responsible to coach less experienced functional group team members pertaining to project execution and new product introduction to develop the company’s capability.
• Support Project Managers to review plans/output to ultimately help improve project deliverables and metrics.
• Collaborate with team members on working across the organization to drive towards a common goal so the company meets its commitments, schedules, and profitability goals by project.

Continuous Improvement Culture- 10%

• Maintain effective communication through projects to consistently surface opportunities and implement improvements.
• Maintain and improve the product development engineering process to improve compliance, schedules, and profit.
• Communicate with the Head of Product Development to provide real time (weekly) key metric performances and feedback to drive improvements in cost and quality issues for the organization.
• Drive a ‘best practice’ and continually improving culture throughout the organization. 
• Acknowledge and reward team members for contributions on a regular basis when role model behaviors are exhibited.

MINIMUM REQUIREMENTS:

• Minimum Requirements: BSEE, BSME or related degree
• Medical device process development and/or medical manufacturing environment experience of 0-4 years.