Manufacturing Engineering Manager

About Scientia Vascular:

Our mission is to save lives. Scientia Vascular is a leading innovator and manufacturer of endovascular medical devices. We use micromachining and microfabrication processes to manufacture products that provide physicians with enhanced performance for optimal outcomes for their patients.

Position Summary:

This role will the manger the interface of manufacturing engineering with the business. This will include but is not be limited to ensuring that capital is purchased to stay ahead of rapid growth, support of cost initiatives as well and new product introduction. Leads cross-functional team development to meet organizational requirements. This role will be accountable to support all deliverables within established financial, schedule, scope and quality objectives.

Primary Responsibilities

• Oversees all Manufacturing Engineering activities
• Supports introduction of new product into manufacturing ensuring that operations have engaged with R&D early enough to ensure that the product is manufacturable. Supports R&D timelines.
• Provides expertise in specification, procurement, build, documentation, validation and personnel training on automated manufacturing equipment.
• Review product field returns with Quality Assurance personnel to determine root cause of potential manufacturing defects and provide process corrective actions if a defect trend analysis documents an unstable process.
• Comply with applicable FDA and international regulatory laws and standards.
• Drive the reduction of variability to ensure that the process remains capable and scalable.
• Implement lean systems and improvements.
• Apply advanced lean and 6-Sigma principles to solve technical and non-technical problems.
• Identify opportunities for process improvements and cost savings. Other responsibilities will include implementing new methodologies, materials, machine processes or products.
• Interface with the production personnel to actively troubleshoot production problems as well as continually improve the process.
• Other duties as assigned with or without accommodation.

Requirements

• Engineering degree
• 5-10 years progressive manufacturing supervision/management and technical experience
• Experience in managing complexity and growing teams
• Team Player
• Medical device manufacturing experience
• Experience with medical device design controls
• Statistical analysis of various types of data
• Strong written and oral communication skills
• Proficient in the use of MS Word, Excel, Project, and PowerPoint
• Mechanical aptitude/trouble shooting
• Lean & 6-sigma experience

Key benefits we provide:

• Medical, Dental, Vision insurance
• Generous Paid Time Off (PTO)
• Paid Parental Leave
• Paid Holidays
• 401k Plan (with a generous employer match)
• Life Insurance (company paid)
• Short-Term & Long-Term Disability Insurance (company paid)
• Subscription to Calm.com
• Employee Assistance Program
• An environment of belonging where everyone can thrive

Commitment to Equal Opportunity:

The Scientia Vascular culture is centered on the principals of equal opportunity for all employees. Consistent with our culture, all qualified applicants will receive consideration for employment without regard to race, color, religion, gender, gender identity or expression, family status, marital status, sexual orientation, national origin, genetics, disability, age, or veteran status, or any other non-merit based or legally protected grounds.

Visit our website and learn more about us at www.scientiavascular.com.