Senior Manufacturing Engineer (Test Methods)

Senior Manufacturing Engineer (Test Methods)

POSITION: Senior Manufacturing Engineer reporting to Senior Engineering Manager

IDEAL CANDIDATE:

The ideal candidate will be an experienced engineer in the medical device industry with a focus on Test Methods. He/She will be an enthusiastic quick learner, patient, committed to the company mission and have the ability to balance the demands of his/her time. An independent, flexible, team player, who is a very good problem solver, has the ability to multi-task, work under pressure, and work in a fast paced environment and deliver on commitments will do well in this role. The ability to communicate verbally and in writing to all levels of the organization from the plant floor to the executive offices is critical. This role has the responsibility to support the New Product Introduction team by developing test methods to ensure adequate product performance for new products and components by performing experiments, testing, and measurements as well as performing equipment validations, process optimizations, and root cause analysis. This role also supports cross-functional Product Development teams with technical inputs to product Design for Manufacturability, Design for Test, product design Hazard Analysis, process FMEA, process and product validations and manufacturing transfer planning. Experience with developing, monitoring and improving component and device test methods (leak & flow, hi-pot, continuity) is required. Knowledge of, and experience with, statistical techniques, hands on experience with SolidWorks or other CAD software is required. SAP experience desirable. Knowledge of MS Office software applications (Project, Visio, and Excel) is required. Knowledge of Minitab is desirable. Skill in operating light assembly tooling and equipment is required. B.S. in Mechanical, Plastic, Biomedical, or Electrical Engineering required. 5-7 years of experience in the medical device engineering field, with emphasis on test methods is required. Six-sigma green or black belt preferred.

Requirements and Responsibilities

The Senior Manufacturing Engineer (Test Methods) has the responsibility to support the New Product Introduction team by developing test methods to ensure adequate product performance for new products and components by performing experiments, testing, and measurements as well as performing equipment validations, process optimizations, and root cause analysis. This role also supports cross-functional Product Development teams with technical inputs to product Design for Manufacturability, Design for Test, product design Hazard Analysis, process FMEA, process and product validations and manufacturing transfer planning.

The Senior Manufacturing Engineer (Test Methods) must be able to prioritize activities and allocate resources for greatest effectiveness.

The Senior Manufacturing Engineer (Test Methods) must deal on a daily basis with both concrete and abstract problems, complex schedules, team and supplier interactions, prioritization and balancing critical thinking with execution.

1. MAIN JOB DUTIES/RESPONSIBILITIES (This section describes the general requirements, principle duties, responsibilities and authorities necessary to perform this job.)

• Develop and / or improve in-process, incoming and final test methods to ensure product, including component and finished device, meets specifications at appropriate sampling levels.
• Develop, implement and validate test methods for new components and devices in the supply chain and manufacturing.
• Collect test performance data and determine appropriate actions from the data. Lead problem resolution.
• Act as site subject matter expert for leak, flow, continuity, hi-pot and other device tests.
• Monitor yields, cycle time and costs to ensure effective and efficient operations within standards.

• Coordinate capital requirements, perform IQ (installation qualification), OQ (operational qualification), and PQ (performance qualification) activities and execute Master Validation Plans.
• Perform engineering, prototype, design verification and manufacturing validation build activities as needed, including required testing.
• Prepares verification and validation protocols for products, equipment, and processes to assure that acceptance criteria are defined and verification and validation activities are completed prior to product, equipment or process use.
• Promote lean approaches and incorporate flexibility within the process such that change is expected, reacted to quickly, and handled with ease.
• Ensure that projects and assigned tasks are completed on time and on budget.
• Monitor the component supply chain such that parts are procured from approved and qualified suppliers and at the established acceptable quality levels.
• Take a responsible role in the manufacturing supply chain such that the Company enjoys strong working relationships with suppliers.
• Participate in product development and transfer teams to ensure that quality and manufacturing tasks are completed on time and issues are raised in a timely manner.
• Communicate often and effectively across all departments regarding projects the manufacturing group is involved in.
• Manage and quickly resolve any issues, questions, or challenges to the manufacturing process.
• Designs and uses analysis systems for trending quality and manufacturing data to assist in providing data for continued improvement of products and services and the quality system.
• Utilize a high degree of systems thinking such that improvements are made continuously and appropriately in areas such as design control, engineering changes, purchasing and procurement, and the general quality system.

2. JOB QUALIFICATIONS (This section describes the qualifications to perform this job.)

• KNOWLEDGE/EDUCATION

• B.S. Mechanical/Plastic/Biomedical/Electrical Engineering required.
• 5-7 years of experience in the medical device engineering field, with emphasis on test methods.
• Six-sigma green or black belt preferred

• JOB EXPERIENCE

• Experience with developing, monitoring and improving component and device test methods (leak & flow, hi-pot, continuity).

• Knowledge of, and experience with, statistical techniques
• Hands on experience with SolidWorks or other CAD software.
• SAP experience desirable.
• Knowledge of Minitab and MS Office software applications (Project, Visio, Excel).
• Skill in operating light assembly tooling and equipment

• COMPETENCIES

• Knowledge of test methods in the medical device industry
• Knowledge of engineered plastic and metals materials for medical devices.
• Knowledge of FDA regulations, GMP's, and ISO compliance.

• SKILLS

• Must have excellent written and verbal communication skills.
• Must have effective data analysis and problem solving skills.
• Must have strong interpersonal and team work skills.
• Must be comfortable with multi-tasking.
• Knowledge of assembly and test methods and machines, in manual and semi-automated manufacturing environments is preferred.

COMPENSATION

• Base salary, experience based