Manufacturing Manager

1.0 SUMMARY AND ROLE OBJECTIVE

The Manufacturing Engineering Manager will play a critical role in the product development and implementation. They will have responsibility for all aspects of manufacturing engineering, specifically supplier management and inventory management of current and future development products, as well as internal manufacturing and distribution logistics. They will be a hands-on contributor and communicator within the organization, interacting with R&D, QA, & Clinical to ensure supply chain management, development, and delivery of quality systems that meet the program objectives.

2.0 ESSENTIAL DUTIES AND RESPONSIBILITIES

Complete responsibility for catheter manufacturing engineering in collaboration with contract manufacturers and component suppliers

Build planning, scheduling, and component budgeting with contract manufacturers, component suppliers, and internal R&D builds

Complete projects at a rapid pace consistent with program timelines

Actively participate in determining day-to-day tasks in accordance with overall project plan and progress

Work closely with internal team members, vendors, subcontractors and contract manufacturers to ensure purchased materials and components meet specifications.

Work cross-functionally with R&D, Quality, and Clinical teams to meet program logistical needs

Document procedures and train engineers and technicians as appropriate

Maintain relationships with component vendors and contract manufacturers

Develop and monitor vendors and manufacturing processes using best practice tools and contribute to program-level documents (ex: FMEA).

Adhere to established company Quality System procedures and provide feedback to procedures in development

Work closely with R&D team members and vendors to design and develop products, including: developing product specifications and documents; design and development of fixtures, tooling, and equipment; providing support for internal builds; transitioning builds to contract manufacturers; supporting ongoing and sustaining contract manufacturer builds

Conduct testing utilizing appropriate methodology & other experimental design tools. Generate test protocols, perform testing, and write reports.

Contribute to the intellectual property position of the company via company brainstorms and review of patent applications when appropriate. Maintain accurate documentation of concepts, designs, drawings, and processes.

Maintain awareness of competitive technologies

Job Description

Manufacturing Engineering Manager

Confidential 2

Provide engineering & technical support of products in development and clinical use

Provide support in the resolution of troubleshooting, failure analyses, product complaints, and/or safety issues

3.0 SUPERVISORY RESPONSIBILITIES

3.1 No direct supervision responsibilities of personnel; however will provide influence of Contract Manufacturer’s activities and priorities.

3.2 Indirect supervision of technicians that support overall program objectives

4.0 QUALIFICATIONS

4.1 Required Experience:

At least 5 years of medical device industry experience

Contract manufacturing or supplier management experience

Experience with process design and improvement and fixture design

4.2 Additional Preferred Experience

Design and development and/or manufacturing of catheters

Familiarity with IEC 60601 and other relevant medical device standards

Design development, verification, and process validation experience, including Design of Experiment (DOE’s), Gage R&R’s, development and execution of V&V protocols, process capability analyses

Experience with planning and execution of product sterilization and release

Inventory management

4.3 Knowledge, Skills, Abilities, and Additional Qualifications

Working knowledge of the environment and expectations of a start-up

Working knowledge of Quality System standard and regulations, Quality Assurance, Regulatory Affairs, and Clinical Affairs

Ability to flex between a leader, contributing team member, and individual, with exceptional interpersonal and negotiating skills to both work within the small team and represent the team to suppliers.

Strong analytical and problem-solving capabilities, using sound engineering, business judgment, and initiative to anticipate and meet near and long-term project objectives and adapt to the rapid pace of the program.

Capability to flex into product development and test method development and execution

Excellent writing skills