Sr Advanced Manufacturing Engineering Manager Disposable Medical Devices

Excellent career opportunity with a well-established firm with an aggressive growth strategy and the revenues and resources to enable it. This exciting engineering management role requires strong analytical skills, the ability to manage teams, and collaborate with customers in the generation and execution of creative design solutions. The company has a highly successful, FDA regulated operation developing and manufacturing high volume metal and plastic medical devices as the OEM provider of choice for major international players.

The position requires a talented manager who can make personal technical contributions, lead a small engineering team, and work effectively with mechanical and manufacturing engineers, and production managers in the US and internationally. He or she will regularly engage with customers to establish their needs, create specifications, and design and develop devices through all phases of the engineering, documentation, and manufacturing transfer process.

Scope of Responsibilities

• Lead new product design, development and documentation from concept

through manufacturing transfer.

• Manage projects for the customer's development process and desired design

elements.

• Support line extensions and maintenance, including design, process and

supplier changes, remediation, and recertification.

• Manage creation of engineering drawings and solid models in SolidWorks 3D.

• Support the sales team in customer technical conversations, costing, and the

redlining process involving input from customers and manufacturing team.

• Support manufacturing equipment design and development.

• Collaborate with Regulatory and Quality Depts. to evaluate product compliance.

• Serve as SME during corporate development efforts.

• Prepare technical documentation for FDA submissions, CE technical file and

design dossiers, etc.

• Remain current with US and International regulations and standards

• Review and write SOPs if gaps are identified.

• Travel internationally 1-2 time a year to company plants.

Requirements and Qualifications

• BS in Mechanical or Manufacturing Engineering or like disciplines; MS is a plus.

• 15+ years of successful disposable medical device development and advanced manufacturing engineering experience, including at least 5 years as a manager.

• Demonstrated ability to lead high volume, single use medical device

projects from concept to commercialization, with knowledge of FDA Class II

device development requirements.

• Experience developing metal medical devices such as needles, surgical

instruments, and trocars, with plastics components a plus.

• Strong project management, planning and organization skills; PMP training

is a plus.

• Ability to work with SolidWorks and CAD software.

• Highly effective customer interaction and communications skills, both oral and

written.

• Ability to travel internationally 1-2 time a year to company plants.