Diagnostics On-Market Product Engineering Lead

Role Description

The DIAGNOSTICS ON-MARKET PRODUCT ENGINEERING MANAGER will work as a member of the research and development team to provide engineering oversight for improvements and updates to diagnostic devices throughout the on market product life cycle. The On-Market Product Engineering Manager will contribute throughout the Stage Gate development process with increasing involvement as the product reaches the Ready to Manufacture (RTM) milestone.  After RTM the On-Market Product Engineering Manager is responsible for guiding all design changes including product design, development, testing, and integration of electro-mechanical, thermal, and optical sub-systems into on-market diagnostic products. The On-Market Product Engineering Manager will apply best practice development strategy and advanced technical concepts to solve complex problems, distilling them down to effective product updates which strike the balance of functionality, usability and minimizing manufacturing and repair impacts. The On-Market Product Engineering Manager will be guided by a stage gate development process prior to RTM and an engineering change control process after RTM. The On-Market Product Engineering Manager will be expected to resolve complex technical challenges that arise during product the product life cycle.

Essential Duties and Responsibilities:

• Carry the leadership role of the product support engineering effort with Manufacturing Transfer, Global Manufacturing & Supply, and Quality such that product commercialization is achieved through product lifecycle and supply base relationships.
• Lead and develop a Product engineering team team
• Responsible for proper engineering oversight of R&D (Engineering) product design change release & collaborative change management process into Product Lifecycle Management release systems (PLM)
• Grow and maintain technical knowledge related to technology and product development of in-vitro diagnostic devices. Including developing product SMEs in multiple engineering disciplines.
• Work with Manufacturing to consider high volume assembly process in design changes and update/maintain product design documents (DFx, DFMEA, FEA).  Analyze and recommend improvements of production processes and methods to facilitate cost reduction and quality improvement.
• Participate in the oversight of Contract Product Manufacturing (external partner/OEM’s) as required
• Develop an understanding and maintain and/or revise electro-mechanical and thermodynamic control sequences in the product requirements, while understanding the interface to electrical control systems and underlying biological process needs for all design changes and updates.
• Prepare documentation for change control activities and efforts.
• Develop and implement mechanical, electrical, and system design changes, perform sensitivity analysis, timing analysis, or other design analysis as required.
• Assessment of system level risks, and proposing, evaluating, and implementing mitigations for all design changes.
• Ensure designs continue to meet and exceed product specifications, regulatory requirements, and international standards after design changes.
• Proficient in communicating complex technical situations in an understandable way to non-technical collaborators.
• Work cross functionally in a global organization, deploy engineering best practices in the context of a change control process, and navigate satisfying product technical specifications as prescribed by customer and market requirements for all design changes.
• Participate in system engineering for complex electromechanical/thermodynamic/optical systems to update product specifications and controls interactions of each system.
• Analyze and recommend corrective actions in case of any design issues.
• Extensive interaction with suppliers in design, analysis, and other technical liaison requirements.

Requirements:

• B.S. in Mechanical/Electrical Engineering, MSME/MSEE. Minimum of 15 years demonstrated engineering experience in a complex engineered product environment.  Quality Management System understanding a must.
• Experience in developing animal health devices or human health devices are a plus
• Experience working with Design and Implementation teams, Operations (Manufacturing, Quality, Metrology) and suppliers from an engineering, technical perspective.
• 5 plus years of experience in people management leading, managing, developing engineering team members
• Technical Skill Requirements: SAP or similar understanding, Engineering Change Management in PLM environment
• Root cause analysis techniques and robust documentation to support engineering best practices.
• Demonstrated proficiency in engineering specific