Job Title: Senior Manager of Manufacturing Engineering
Reports To: VP of Operations
FLSA Status: Exempt
Department: Operations

Summary: This position is directly responsible for ensuring all manufacturing processes are scalable and required capacity is available to support commercial volume levels at established COGS target and with no degradation to product quality (yields). This includes ensuring an adequate capacity is in place for both internal and supplier processes. This position will also serve as the manufacturing point person for new product development projects led by R&D. This position will work closely with project members to ensure products are adequately designed for manufacturability. This position will serve as department head of Manufacturing Engineering- Cartridges and provide leadership and guidance to department personnel. The Senior Manager will be responsible for the department’s budget including capital equipment planning as it relates to manufacturing improvements and capacity.

Essential Duties and Responsibilities include the following. Other duties may be assigned.

• Provides the technical leadership required to successfully qualify and validate components, sub-systems and final assemblies and manufacturing processes.
• Directly responsible for the development of a service program to maintain our meters in the field for sustained periods of time. This includes establishing an ongoing reliability program to determine the edges of component and system failure. Creates or reviews/approves budgets and forecasts and works within budget to achieve agreed-upon milestones as it relates to COGS, capacity, yield and product complaints.
• Ensure a robust, well documented set of design control documents are readily available to support regulatory filings including component and equipment drawings, BOMs, travelers, DMR and other relevant quality system documents used to manufacture product.
• Supports company goals and objectives, policies and procedures, Quality System Regulation, and FDA/MDD regulations.

Knowledge, Skill and Competency Requirements:
To perform the job successfully, an individual should demonstrate the following knowledge, skills and competencies:

• Minimum of 10 years experience in medical device manufacturing with a minimum of 5 years management experience.
• Must have experience working with complex medical devices having both a disposable, reusable and software component.
• Must have an excellent understanding of design verification and validation, design of experiments, test method validation and process validation.
• Must have experience working within a concurrent engineering design model whereby product design and process development occurs in parallel (design for manufacturability).
• Must be able to apply the appropriate level of “Good Laboratory Practice” control and scientific discipline when collecting data that supports a hypothesis.
• Must be a strong people manager with demonstrated leadership experience creating a high performance team with the ability to be collaborative cross functionally.
• Must have stellar verbal and written communication skills.
• Must be very creative and have demonstrated skills working within the confines of a start-up environment where resources are limited.
• Must be a “working / hands-on” leader.
• Must have a good understanding of IEC 60601 standards as well as applicable EN13485 and 21CFR820 requirements as they relate to manufacturing and design control, development, process validation, and product acceptance testing.
• Ability to work with cross-functional teams, problem solve and drive solutions to meet internal and external customer requirements.
• Proficient in Microsoft Office Applications (Project, Power Point, Visio, Excel, Word) as well as MiniTab, Solid Works or other CAD software.
• Ability to travel, domestic and internationally as needed.

Must have a Bachelor’s/Master’s degree in Mechanical Engineering or related discipline or equivalent work experience from a top ranked engineering program.

A minimum of 10 years experience working in cGMP/FDA regulated industry.

Must have a heavy concentration of experience in disposable product manufacturing.

Supervisory Responsibilities:
Supervisory responsibility for Manufacturing Engineering personnel. Must be an excellent teacher and mentor and demonstrate a ” hands on” leadership style.

Required Training:
The area supervisor or depmiment head (or delegate) shall determine what internal training (if any) is required in order to satisfactorily meet the job requirements listed above. Such training shall be conducted in accordance with applicable SOPs and said training shall be documented in accordance to our internal training procedure. The employee shall also receive general training in both 21CFR 820 and EN13485 as well as the OptiScan Quality Manual and Quality Policy.

This job description does not state nor imply that the above are the only duties and responsibilities assigned to this position. Employees holding this position will be required to perform any other job related duties as requested by management and will also be required to meet safety-related requirements. All requirements are subject to possible modification to reasonably accommodate individuals with a disability.

If you are interested in applying to an open position at OptiScan, please email your resume to [email protected]