Summary:

The New Product Introduction Engineer is directly responsible for engineering support for both new and existing projects under NPI Product Development processes.  Engineering support includes device design, DHF/DMR documentation, execution of design/process verification and validation, and quality system compliance.
 
The position reports directly to the Head of Product Development

Key Accountabilities:

NPI Product Development Engineering- 40%
Accountable to support engineering tasks derived from Client product performance, product safety, product cost, product regulatory, and product quality requirements are completed per project schedule and budget.
 
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.

Primary Responsibilities:

NPI Product Development Engineering- 40%

• Execute development or remediation of Client design history file (DHF) per scope of work listed in Client proposal to ensure regulatory compliance and Client design performance requirements are achieved.
• Track and report, to the Project manager, on Client design performance, design safety, design regulatory, and design quality requirements to ensure budget and schedule are achieved.
• Execute project deliverables with all functional groups to enable the company to meet deliverables, schedule, and budgets to meet client requirements. 
• Responsible for creating necessary content for design reviews, assigned by Project Manager, with the assigned functional team members.
• Support the Project Manager to initiate and execute the design change process to ensure that issues are identified, resolved, and implemented to minimize impact to the NPI schedule.
• Support the development and execution of design verification and validation; test plans, test protocols, test reports to ensure design output meet design input.
• Lead the training of NPI engineers (as applicable) and technicians to ensure transfer of product design knowledge.
• Collaborate with the Project Manager, Client, and Buyer to select, approve, and partner with suppliers and third-party consultants to ensure delivery and product completion align with project timelines and expectations.
• Participate in post-project retrospectives (driven by the Project Manager) to understand the project successes measured against original client requirements.

NPI Manufacturing Engineering Support – 40%

• Execute development or remediation of Client device master record (DMR); specifications, manufacture process instruction, in-process test methods, and lot history records to ensure regulatory compliance and Client process performance requirements are achieved and meet design output requirements.
• Collaborate with Manufacturing Engineering for process reviews and manufacturing process training for Production operator(s) to ensure transfer of knowledge (as applicable).
• Support the development and execution of process validation; test plans, test protocols, test reports to ensure process output meet design input
• Collaborate with the Project Manager, Manufacturing Engineering, and Buyer to select, approve, and partner with suppliers and third-party consultants to ensure delivery and product completion align with project timelines and expectations.
• Participate in post-project retrospectives for Manufacturing Transfer projects (driven by the Project Manager) to understand the project successes measured against original client requirements.

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.

Education and Experience:

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

Compensation Range:

• $55,000 – $120,000 per year (depending on experience)