Process Development Engineer

Manufacturing Engineer Sr - Nitinol Products

The Senior Manufacturing Engineer will be responsible for leading the development and deployment of manufacturing processes of Nitinol based products. and implementation of improvements including cost, manufacturability, and quality goals. Responsible for planning, designing, developing, and maintaining manufacturing processes. Provide direction and support once products are deployed into production including support to the Manufacturing organization to facilitate efficient operations within the production area, to optimize existing processes and to ensure that production goals are met.

Responsibilities

- Initiate and complete technical activities for new or improved Nitinol processes or design for manufacturability for current and next generation programs

- Hands on position to design, develop, and validate Nitinol based manufacturing processes

- Ability to read and interpret engineering drawings; ability to design tooling and fixtures in 3D CAD Software

- Coordinate fabrication and implementation of process fixturing or gauging

- Interface with quality and manufacturing to integrate new products or processes into production to meet strategic goals and objectives of the company

- Create, maintain and approve device routers, manufacturing procedures, and bill of materials

- Monitor performance of equipment, machines, and tools and corrects equipment problems or process parameters that produce non-conforming products, low yields, or product quality issues

- Resolve non-conformances and participates on Material Review Board

- Analyze and map processes, assesses efficiency, and implements complex project activities

- Mentor Engineer I and II and Technicians

- Support and comply with the company Quality System, ISO, and medical device requirements

- Read, understand, and follow work instructions and standard work

- Partner with other business segments: sales/marketing, customer service, engineering, quality, and finance

- Understand customer needs and the core business markets we serve

Qualifications

- Bachelors Degree in Mechanical, Biomedical, or Material Science Engineering

- 7 years of engineering experience in a manufacturing setting

- Prefer 1+ years of engineering experience in a Nitinol manufacturing setting; including state of the art manufacturing technology/concepts and cost reductions

- Fundamental understanding of the properties and behaviors of Nitinol; understanding of Nitinol related processes with emphasis on Shape Setting

- Experience with 3D CAD Software (i.e. Solidworks)

- Team dynamic skills (communication, accountability, decision-making, feedback, meeting management, managing conflict)

- DOE, SPC, FMEA, GDP, QSR, GD&T, ANOVA

- Experience with statistical softwares (i.e. Minitab, Excel SPC, etc.)

- Project management experience

- Excellent communication and influencing skills

- High level of energy, personal accountability, and integrity

- Highly detail oriented; checks own work, keeps accurate records, organizes data effectively

- Ability to tolerate ambiguity, multiple priorities, and short deadlines

- Microsoft Office proficiency (Outlook, Word, Excel, PowerPoint, Publisher)

- Experience in an ISO13485/GMP environment

- Ability to work in a fast-paced team environment, prioritize work and multitask

Preferred Knowledge, Skills and Abilities

- Masters Degree in Mechanical, Biomedical, or Material Science Engineering

- 5+ years of engineering experience in a Nitinol manufacturing setting; including state of the art manufacturing technology/concepts and cost reductions

- Experience with testing Nitinol material for Af, tensile, fatigue, cyclic loading, and corrosion

- Continuing Education; including participation in local chapters, associations, and/or organizations

Job Type: Full-time

Pay: $100,000.00 - $140,000.00 per year

Work Location: In person