Engineering Mgr - Equipment Process Engineering

By living according to a common set of values, we create a culture that unifies, embraces the uniqueness we all bring to the company, and positions Integer for long-term success.

At Integer, our values are embedded in everything we do.

Customer

We focus on our customers' success

Innovation

We create better solutions

Collaboration

We create success together

Inclusion

We always interact with others respectfully

Candor

We are open and honest with one another

Integrity

We do the right things and do things right

Job Summary:

This position will lead direction and efforts in design and development of Mfg. and R&D fixtures and equipment for medical device assembly processes with work including writing or verifying specifications, sustaining product process, designing fixtures, test processes, equipment and raw materials to ensure that the subassemblies and finished products meet their design requirements. The Manager will conceptualize and spearhead projects in design and development of electromechanical automated and semi-automated manufacturing equipment. This position will lead a team of engineers and technicians that are responsible for authoring equipment specifications, generating schematics and drawings, and building complex capital equipment and process fixture designs. Work closely with Quality, Regulatory, and external customers in supporting the development of new products and manufacturing processes to achieve a smooth, successful transfer to Manufacturing Engineering and production launch. In conjunction, this position will work closely with development project engineering teams to develop new manufacturing processes from design conceptualization through to validation and production

Accountabilities & Responsibilities:

• Leads a team of engineers and technicians designing and developing process around new equipment and fixturing to improve mfg. process capability, capacity, efficiency, cost, and quality
• Manages a team of engineers that lead projects to design improvements to existing R&D and manufacturing. process equipment, tooling, and fixturing
• Leads analysis of data and improve processes to assure robust/repeatable manufacturing processes
• Confers with appropriate departments, resources, and/or outside services to prepare process modifications, clarify problems and develop processes
• Manage process validation and product transfer activities across different manufacturing facilities and product lines
• Track status of team's assigned priority projects and regularly report to management
• Train and mentor engineering skills and task execution using established procedures related to equipment selection, schematic design, system layout, cost estimation and system documentation
• Interface with cross-functional departments to execute manufacturing process and equipment development projects
• Provide technical direction to engineering staff
• Adheres to Integer's Values and all safety, environmental, security and quality requirements including, but not limited to: Quality Management Systems (QMS), Safety, Environmental and Security Management Systems, U.S. Food and Drug Administration (FDA) regulations, company policies and operating procedures, and other regulatory requirements.
• Other duties as assigned.

Education & Experience:

• Bachelor of Science in Engineering or related engineering field
• 10+ years directly related experience; 5+ years of managing engineering professionals in Medical Device development
• Demonstrated expertise with inferential statistical process analysis techniques
• Demonstrated expertise with mechanical design methods using Solidworks
• Medical device industry experience
• Experience with reading and preparing technical documentation a must
• Excellent communication skills and demonstrated ability to build a healthy, productive, high-performing team culture

Knowledge & Skills:

• Expert in Process Validations in medical device manufacturing environment
• Expert in statistical process analysis tools, including Design of Experiments (DOE) and Cpk for process development characterization and optimization
• Solid proficiency in technical documentation, including CAD modeling and engineering drawings
• Demonstrated expertise related to design and development of mfg. equipment, fixturing, and tooling
• Knowledge of mechanical design with SolidWorks
• Working knowledge of conventional and CNC machining processes
• Must have good written and verbal communication skills, be well-organized, ability to work in a fast-paced self-directed environment
• Good document control and record-keeping skills
• Ability to organize, prioritize and meet deadlines in a timely manner
• Special Skills: Business mindset with strong analytical and critical thinking skills to present
• Specialized Knowledge: To be impactful in the role, you must be a strategic thinker with a high level of attention to detail.

Salary Range: $123,750.00 - $165,000.00

U.S. Applicants: EOE/AA Disability/Veteran