We're looking for a mechanical engineer to join its drug delivery team in Madison, Wisconsin. This opportunity is for a term of up to one year.
The client provides Life Care Solutions Anesthesia Drug Delivery business is developing two new product offerings based on existing technology for a strategic pharmaceutical customer. The purpose of this position is to support product development activities throughout the entire new product introduction (NPI) process. The successful candidate will partner with other engineers, cross functional team members, and project leadership to complete product development lifecycle deliverables ranging from initial concept refinement to product launch.
- Research legacy product design and documentation.
- Plan project activities for assigned scope of responsibility. Identifying necessary human and financial resources. Contribute to overall project milestone planning.
- Author design input documents including user requirements, product specifications, standards requirements, and system architecture specifications.
- Evaluate product safety using formal risk management and failure modes and effects (FMEA) methods.
- Enhance existing product and part functional specifications.
- Generate and evaluate new component and subsystems designs using 3D CAD modeling (Pro-Engineer) and rapid prototyping techniques. Please note that CAD is a relatively small portion of the overall responsibilities for this position (approximately 5%).
- Detail finished engineering drawings using 2D CAD (Pro-Engineer) and release into PDM system (Agile) and EPR system (Oracle).
- Release product bills of material structures (Agile).
- Participate in and lead technical and formal design reviews for assigned parts, subsystems, and systems.
- Partner with sourcing, supplier quality, and strategic suppliers to procure engineering prototypes and establish reliable, qualified supply chains for initial production.
- Assemble prototype devices.
- Write verification and validation strategies, plans, and procedures.
- Execute verification and validation activities (tolerance analyses, functional and lifecycle reliability testing and analysis, usability studies, etc.) and formally document in written reports.
- Resolve design issues and document design changes using the engineering change request (Agile ECR), engineering change order (Agile ECO), and defect management processes (Clearquest).
- Partner with manufacturing engineering and operations to establish and qualify production assembly and test processes.
- Assist with the preparation of technical content for regulatory submission (FDA, CE, etc.).
- Maintain history record (DHF), device master record (DMR) and CE technical file documentation.
Basic Qualifications (no exceptions):
- BS degree in Mechanical Engineering.
- Minimum 3 years of experience sustaining or developing complex electro-mechanical systems.
- Willing to interview in person and work from the Madison, Wisconsin location.
- History of stable employment and demonstrated contributions both as an individual and team member.
- Proven experience completing project deliverables on-time while meeting stringent quality standards.
- MS in Mechanical Engineering.
- 5-10 years mechanical engineering experience developing regulated electro-mechanical medical devices.
- Experience qualifying materials for use in medical device application.
- Experience developing closed systems for handling pressurized multi-phase flows (liquid and gas).
- Demonstrated strong communications, influencing, and team leadership skills.