Director of Manufacturing Engineering

Responsibilities


Provide engineering, operational, Lean manufacturing, Six Sigma leadership and mentoring.

Collaborating with all department leaders, provide technical leadership to the organization with a focus on manufacturing engineering.

Maintain positive, high performance environment that fosters extraordinary customer satisfaction.

Maintain compliance to the Cogmedix Quality System.

Provide leadership to organization and manufacturing engineer(s) on their primary responsibilities, outlined below:

Engineering Change Orders

BOM management; creation of PNs, supplier relationships

Process qualification/validation development and execution

PFMEAs

Value Stream Mapping / Process Flows

Time Studies

Lean cell design and implementation

Procedure updates and training

Test fixture updates and validation

Production troubleshooting

Preparation of Redline documentation

Rework Instruction generation and review

Risk analysis

Co-build and pilot build activities

Ensure Customer to Cogmedix BOM accuracy through various electronic means.

Provide technical support and leadership to SPLs.

Collaborate with Project Managers and Quality Engineers to analyze Redlines, customer ECOs and ensure effective implementation to the production floor through proper use of the Cogmedix ECO process, including reviewing and communicating with internal groups and customers on impacts of any changes (e.g., financial, inventory, WIP, open supplier orders, etc.).

Promptly respond to manufacturing floor quality issues, taking appropriate action within the Cogmedix Quality System and continually building strong rapport with customers and suppliers.

Collaborate with PMs and Quality Engineers to develop optimal work order routings and Device History Records.

Support the development of quality and inspection plans.

Collaborate with internal groups and customers to help determine root cause of customer issues, Complaints, and CAPAs. Maintain compliance to the Cogmedix Quality System.

Effectively interact with customers and internal departments to create value propositions.

Working with all internal groups, identify trends and process gaps and suggest corrective actions and process improvements.

Collaborate and support DFcx Engineering programs.

Train Manufacturing Engineers and Engineering Document Control Specialists.

Other responsibilities as directed.

Essential Requirements


Positive attitude, excellent communications skills, self-motivator, tenacious follow up, and superior organization skills.

Superior customer service attitude.

Bachelors degree in science, engineering, or manufacturing discipline. Twenty or more years of related manufacturing experience and technical document control may be considered in lieu of certain educational requirements.

20+ years professional experience in manufacturing industry medical subassembly and finished device manufacturing preferred.

Excellent organizational skills with a commitment to meeting deadlines and expectations while ensuring overall compliance and quality of delivery.

Demonstrated ability to build effective business relationships across all levels of internal and external business.

Excellent technical, problem solving and analytical abilities.

Strong quality mindset a must. Experience with electronic quality management systems desirable.

Must be flexible, possess strong leadership and interpersonal communication skills; ability to manage multiple priorities and lead a team.

Strong decision making capabilities and capacity to handle confidential information.

Advanced Level Skills in MS Word, Excel and PowerPoint such as keyboard short cuts, creating forms, table techniques, working with images, text, and pivot tables preferred.

A demonstrated commitment to company values.

Strong electro-mechanical and opto-mechanical orientation.

Advanced working knowledge of Lean concepts and Six Sigma Black Belt training.




Cogmedix is an Equal Opportunity Employer. Cogmedix does not discriminate on the basis of race, religion, color, sex, gender identity, sexual orientation, age, non-disqualifying physical or mental disability, national origin, veteran status or any other basis covered by appropriate law. All employment is decided on the basis of qualifications, merit, and business need.