Job Title: Automation Specialist - High-Volume Manufacturing Lines
A career at our organization is only for those who want to do something extraordinary with a meaningful purpose: imagine, develop and deliver a better future with our customers. We are a leader in high-reliability design, manufacturing and supply chain solutions that bring global expertise to every stage of product development.
We are seeking an experienced Automation Specialist to lead the development and implementation of fully automated high-volume manufacturing lines from the development stage to full-scale production ramp, producing world-class medical devices in a dynamic, fast-moving environment.
The ideal candidate will have extensive experience using engineering tools and software packages to design and automate complex manufacturing processes. They will be able to effectively communicate manufacturing plans, proposals, and results, and negotiate options at executive management levels. Exceptional analytical and problem-solving skills are essential.
About the Role:
- Lead the development and implementation of fully automated high-volume manufacturing lines
- Oversee the performance of equipment, machines, and tools using advanced statistical methodologies
- Champion and drive continuous improvement processes for production areas using structured Process Capability and Lean Six Sigma methodologies
- Collaborate with cross-functional teams to integrate new products, processes, and technologies into the existing manufacturing area
- Develop automated solutions for NPI programs, including new business development opportunities
What We Offer:
- Market-competitive total reward: flexible salary, fix and variable salary based on goals
- The opportunity to innovate, learn, mentor others, and work toward your own vision of career success
- A global, collaborative culture with strong leadership imperatives to foster your growth and professional opportunities
Requirements:
- A minimum of 4+ years' experience in a Process Engineering role, with a proven track record of leading projects and teams
- Extensive experience in creating CAPA, FMEA, SOP's, Control Plans, and performing validation (FAT, SAT, IQ, OQ, PQ)
- Demonstrated ability to effectively communicate manufacturing plans, proposals, and results, and negotiate options at executive management levels
- Exceptional analytical and problem-solving skills
- Excellent interpersonal and communication skills
Bonus Requirements:
- Medical Device AND/OR Automation experience is essential
- In-depth knowledge of the medical device industry and of 21 CFR, specifically in the areas of Change Control and Validation
- Strong leader with the ability to initiate and lead change, collaborate and create alignment, drive accountability, think critically, and make sound decisions