Senior Medical Manufacturing Engineer

Great opportunity with growing organization. Plastics experience with molding, options, etc...  Mini-cad, solid-works, and sigma six Green Belt experience needed.  Medical Device experience a must.

Work with cross functional teams on quality, quality assurance etc.

Title:                           

SENIOR MANUFACTURING ENGINEER 

Department:   

Operations 

GENERAL PURPOSE – Supports cross-functional Product Development teams and Operations with technical inputs to product Design for Manufacturability, product design Hazard Analysis, process FMEA and manufacturing transfer planning. 

SUPERVISION RECEIVED – Reports to the Director of Manufacturing Engineering  

SUPERVISION EXERCISED – None 

ESSENTIAL DUTIES AND RESPONSIBILITIES –

• Provide plastics manufacturing, materials and design expertise to operations, engineering, CM’s, QA and vendor base in a medical device product environment. Coordinate plastics tooling and part debug efforts in mfg per corporate procedures and Stds.
• Provide CAD support to operations and engineering document control for product development, cost savings projects and document support in a medical device product environment. Mold filling analysis (Simpoe) would be a plus.
• Lead Lean initiatives to eliminate Muda in existing and future manufacturing operations with Contract Manufacturers and internal Manufacturing.
• Manage and quickly resolve any issues, questions, or challenges to the manufacturing process.
• Promote flexibility within the development process such that change is expected, reacted to quickly, and handled with ease.
• Ensure that projects are completed on time and on budget.
• Monitor the component supply chain such that parts are procured through Supply Chain Group when and where they are expected, and at the established acceptable quality levels.
• Take a responsible role in the manufacturing supply chain such that Salient Surgical enjoys strong working relationships with OEMs and component suppliers.
• Communicate often and effectively across all departments regarding projects the manufacturing group is involved in.
• Utilize a high degree of systems thinking such that improvements are made continuously and appropriately to the present needs of the company in areas such as design control, engineering changes, purchasing and procurement, and the general quality system.

 DESIRED MINIMUM QUALIFICATIONS

Education and experience:

1.      B.S. Mechanical/Plastic/Industrial Engineering required.

2.      5 years minimum track record of leading cross-functional teams through to successful, on-time launches of novel new products, plus 5 years minimum experience in development and manufacturing implementation of disposable medical devices. Must have a hands-on, implementer type personality.

3.      Plastics injection and insert molding process, DFM/DFA, materials experience with medical device applications with an emphasis on high quality and capable manufacturing in low to moderate volume applications.

4.      Plastics Tooling, debug, secondaries experience. Hands on processing experience a plus.

5.      CAD experience with Solid Works. Mold filling CAE experience with Simpoe a plus.

6.      Experience with transfer of disposable medical device production to offshore or domestic secondary source.

7.      Ability to manage and complete large project work loads quickly, accurately and efficiently.Manage and quickly resolve any issues, questions, or challenges to the manufacturing process.

8.      Green Belt or better in Lean Mfg or 6 Sigma with Focus on Lean is desirable and a plus.  Hands on experience value streaming and coordinating creation of value streams with Contract Manufacturers and other Manufacturing Engineers  Hands on experience with Takt time vs. cycle times and cycle time reductions with single piece mfg assembly flows.  Hands on experience developing process flows.  Hands on experience leading and participating in Kaizen events to attack Muda.

9.      Hands on experience working with Contract Manufacturers

10.  Hands on experience with Minitab

11.  Hands on experience developing assembly instructions.

12.  Line layout experience.

13.  Fab Tooling, Processing and Part Design experience

14.  Automation Experience

15.  Promote flexibility within the development process such that change is expected, reacted to quickly, and handled with ease.

16.  Ensure that projects are completed on time and on budget.

17.  Monitor the component supply chain such that parts are procured when and where they are expected, and at the established acceptable quality levels

.18.  Take a responsible role in the manufacturing supply chain such that this company enjoys strong working relationships with OEMs and component suppliers.

19.  Work closely and effectively with contract manufacturers and vendors to evaluate and champion root cause evaluations as needed for NCMR or SCAR closure.

20.  Communicate often and effectively across all departments regarding projects the manufacturing group is involved in.

21.  Assist in engineering change orders by correcting documents and updating CAD model using SolidWorks.

22.  Work with documentation manager to maintain vault system for CAD drawings. 

Necessary knowledge, skills and abilities:

1.      Must have excellent communication, interpersonal and leadership skills.

2.      Must be comfortable with multi-tasking.

3.      Extensive knowledge of assembly and test methods and machines, in manual and semi-automated manufacturing environments is necessary.

4.      Extensive knowledge of engineered plastic and metals materials for medical devices is necessary.

5.      Must have solid knowledge of FDA regulations and ISO compliance

6.      Must have working knowledge of CAD and basic computer spreadsheets 

TOOLS AND EQUIPMENT USED -- personal computer, including word-processing, spreadsheet, and database software; motor vehicle; phone. 

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.  Work is performed mostly in office settings.  Hand-eye coordination is necessary to operate instruments, computers, and various pieces of office and surgical equipment.  While performing the duties of this job, the employee is required to use hands to finger, handle, feel or operate objects, tools, or controls; and reach with hands and arms.  The employee is occasionally required to sit; climb or balance; stoop, kneel, crouch, or crawl; talk or hear; and smell.  The employee must occasionally lift or move up to 25 pounds.  Specific vision abilities required by this job include close vision, distance vision, color vision, peripheral vision, depth perception, and the ability to adjust focus. 

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.  The employee occasionally works near moving mechanical parts and is occasionally exposed to fumes or airborne particles, toxic or caustic chemicals, and risk of electrical shock.  The noise level in the work environment is usually quiet to moderate. 

SELECTION GUIDELINES -- formal application, rating of education and experience; oral interview and reference check; job related tests may be required. The duties listed above are intended only as illustrations of the various types of work that may be performed.  The omission of specific statements of duties does not exclude them from the position if the work is similar, related, or a logical assignment to the position. The job description does not constitute an employment agreement between the employer and employee and is subject to change by the employer as the needs of the employer and requirements of the job change.