DESCRIPTION:
The Resonetics Sr. NPI (New Product Introduction) Engineer is a key member of the team ensuring Resonetics’ ability to develop cutting edge medical device products and manufacturing capabilities from early stage design through successful market introduction and launch. They work in unison as a core team member with the Product Development and Quality Engineering functions to implement new technologies and processes, and ensure successful and timely transfer to clinical, pilot-line, and commercial production while meeting established goals (i.e., safety, quality, delivery, cost, and productivity). The Sr. NPI Engineer develops, selects, and optimizes systems for component and assembly manufacturing based on planned demand, location, and quality requirements. In addition, the Sr. NPI Engineer plays a key role in selection, vetting, and coordination of external supply chain. As programs progress into commercial manufacturing, the Sr. NPI Engineer acts as a technical liaison and key member of the transfer team to facilitate efficient training of production resources. As an experienced resource, the Sr. NPI Engineer is expected to help establish best practices, train junior resources, and resolve complex technical and business challenges using formal engineering rigor and data driven decisions.
RESPONSIBILITIES:
- Design and develop manufacturing procedures, tooling, and fixtures that result in sufficient capacity to meet customer demand while also promoting product quality, process efficiency, and operator safety.
- Provide production line support including, but not limited to, implementing process improvements, troubleshooting equipment, and addressing operator inquiries.
- Generate and modify manufacturing process documentation and assure that manufacturing processes and related documentation follow established policies and procedures per Resonetics’ established Quality Management System.
- Utilize LEAN, Six Sigma, DMAIC and other process improvement tools and principles as appropriate for day-to-day problem solving and continuous improvement.
- Develop and release new products and processes using customer or internal specifications.
- Write and execute process and equipment validations (IQ/OQ/PQ/MVP/TMV), as well as associated risk management activities (PFMEA/Risk Assessment).
- Drive utilization of process improvement techniques to solve technical problems and make scale-appropriate equipment and process recommendations.
- Design and prepare engineering reports, communicate results to technical team, customer, and leadership audiences.
- Complete and manage Capital Equipment Requests associated with project work.
- Create process documentation and execute training where applicable (Manufacturing Process, Equipment Setup, Preventive Maintenance etc.).
REQUIRED QUALIFICATIONS:
- (BS or MS) in relevant Engineering discipline or equivalent experience.
- Minimum of 6 years experience in a manufacturing environment working in an engineering role.
- Strong communication skills, comfortable with leading and providing project status updates at the team, customer, and leaderships levels.
- Demonstrated work ethic and understanding of deadline management.
- Strong analytical skills with the ability to process operational or technical data and translate the output into a business result or opportunity.
- Familiarity with conventional statistical analyses (process capability, equivalence studies, regression, ANOVA, DOE).
- Experience with Statistical Process Control (SPC).
- Proficient in SolidWorks (or equivalent) for tooling/fixture design. Well versed in GD&T and generation of technical drawings.
- Excellent writing skills, able to write detailed reports, comprehensive manufacturing procedures and validation reports/protocols.
- Training and/or experience in formal problem-solving techniques (Cause & effect analysis, 5 Why’s, etc.)
- Effective interpersonal skills and adeptness in working with culturally diverse employee population.
- Ability to drive task clarity in a fast-paced environment with cross-functional stakeholders.
PREFERRED QUALIFICATIONS:
- Certification or training in Lean Six Sigma methodology and DMAIC principles.
- Project management, planning, and leadership skills.
- Experience with catheter processing equipment including hot boxes, laminators, split die bonders and tipping machines
- Experience working in a medical device or regulated environment.
PHYSICAL DEMANDS:
- Standing and walking for short periods of time
- Ability to use a microscope, including manipulating small objects under a microscope
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