Manufacturing Engineer with Tissue Processing exp.

Client: Medtronics

Medtronic is the world’s largest medical technology company, offering an unprecedented breadth and depth of innovative therapies to fulfill our Mission of alleviating pain, restoring health, and extending life. Last year, more than 9 million people benefited from our medical therapies, which treat cardiac and vascular diseases, diabetes, and neurological and musculoskeletal conditions.

Eatontown, NJ
What we do at this location: We deal with the donation of life and then process bone, tissue, etc to make other products that enhance other people's lives.

Creates processes, identifies/designs tooling and equipment to manufacture bone and soft tissue products. Initiates and modifies routers, BOM’s, and recipes for SAP needed to process tissue products to meet design/validation requirements, regulatory requirements, and safety needs. Initiates changes to manufacturing methods/processes to improve quality, reduce manufacturing costs, and reduce lead-time. Collaborates with quality engineers to disposition WIP, and complete CAPA’s as needed. May initiate inspection and test requirements into the production plan. Works with cross-functional groups to implement new products. Provides guidance to Product Development Engineering regarding design concepts and specification requirements to best utilize equipment and manufacturing techniques. Collaborates with engineering team, manufacturing, and finance on costing issues and CAR requests. Works with minimal supervision.

FUNCTIONING FACTORS

Knowledge:  Applies intermediate knowledge of practices and procedures focused in one job family or broad knowledge across a job function.

Problem Solving: Provides solutions to a variety of problems of moderate scope and complexity.

Discretion / Latitude: Works under general supervision. Follows established procedures. Work is reviewed for soundness of judgment and overall adequacy.

Impact: Contributes to the completion of milestones associated with work group objectives. Failure to achieve results or erroneous decisions or recommendations may cause delays in program schedules and may result in the allocation of additional resources.

Liaison: Internal interactions extend beyond the immediate work group. External interactions are transactional, task oriented, or problem solving in nature.

Adhere to the Medtronic Core Behaviors of Customer Focus, Candor, Trust and Respect, Courage, Accountability, and Passion to Win.

OTHER SKILLS and ABILITIES:

• Experience with Bone and/or Tissue Processing in an aseptic environment a plus
• Experience with and effective application of Design for Inspectability, Validation Protocol and Report creation, Equipment and Process Validations (IQ, OQ, PQ, and PV), GD&T, MSA, DOE's, Design and Process FMEA's , SPC, Process Control Plans, Gauging applications, design, and construction, Sampling methodologies, Data Analysis.
• Experience with and understanding of Machining, Passivation, Molding, Cleaning, Forming, and Assembly.
• Six Sigma and Lean Manufacturing.
• Design Verification and Validation activities
• Effective communication skills, both verbal and written.
• Effective interaction with personnel at diverse positions within and outside of the organization.
• Value other’s ideas and experience working in a team environment.
• Able to work well with a diverse group of people both within the organization as well as with people outside the company.
• Project Management experience or training. Work well under pressure, organized and able to attain results on several projects simultaneously.
• Effective analytical and problem-solving skills and experience applying these skills to resolve technical problems in a manufacturing environment.
• Knowledgeable on manufacturing methods and equipment.
• Understanding of the product development process and its needs
• Results oriented and self starter.

Travel may be required

Minimum Educ and Exp:

Bachelors degree in engineering or related technical field with a minimum of 2 years of medical device or related experience, or

Masters degree in engineering or related field

Preferred Educ and Exp:

This job may be used across various product groups or functions. There may be specific education, experience or skills based on the department.

PHYSICAL DEMANDS: The physical demands described here are representative of those that must be met by an employee to successfully perform the essential functions of this job. Reasonable accommodations may be made to enable individuals with disabilities to perform the essential functions.

While performing the duties of this job, the employee is regularly required to sit and talk or hear. The employee frequently is required to stand; walk; and use hands to finger, handle, or feel objects, tools, or controls. The employee is occasionally required to reach with hands and arms. The employee must occasionally lift and/or move up to 15 pounds. Specific vision abilities required by this job involve normal vision.

WORK ENVIRONMENT: The work environment characteristics described here are representative of those an employee encounters while performing the essential functions of this job. Reasonable accommodations may be made to enable individuals with disabilities to perform the essential functions.