Senior Manufacturing Engineer OCE

招聘人数：1-2人 到岗时间：不限 年龄要求：不限 婚况要求：婚姻状况 1. Experience with and high level of understanding of stage-gate product development processes
2. Act as key liaison between Operations organization and new product development teams
3. OCE is responsible for business planning activities related to New Product Introduction & Commercialization, including Manufacturing Site Selection, Product Lifecycle Planning, Overall Supply Chain Capacity Analysis, and Capital Expenditure Strategy
4. Partner with Supply Chain and AME team to develop production build plan for all raw materials and finished goods in order to achieve Time to Market (TTM) and Time to Ramp (TTR) targets
5. Provides operations input for supplier selection and process development activities
6. Conceptual leader for technology advances associated with tooling and process development.
7. Maintain global awareness of manufacturing strategies & capabilities and provide insights into technology specialties across the global manufacturing sites to project core teams.
8. Advise management of developments which may affect profit, schedule and costs.
9. Communicate and coordinate project activities with multiple functional groups both within and outside of operations
10. Ability to manage multiple initiatives simultaneously
11. Demonstrated leadership and management skills
12. Candidate must have the ability to work independently and be able to communicate effectively with team members.
13. Ability to meet at off hours to support business partners located across the globe with global time zone differences.





1. Ensures adherence to product specifications, industry standards, and quality and regulatory procedures and requirements.
2. Support process verification and validation testing activities.
3. Assist with selection and qualification of new materials and suppliers.
4. Other duties as assigned with or without accommodation.

MINIMUM REQUIREMENTS:
Education: B.S. in Engineering, Manufacturing, or other technical field.
Experience: A minimum of 7-10 years of experience, preferably working in medical device manufacturing.

Preferred Skills/Qualifications:
Experience working with FDA Quality Systems Regulations and ISO Quality Systems.
Familiarity with SPC, Experimental Design, and Statistical Sampling Techniques.
Trained/Certified in Lean and/or 6 Sigma
Working knowledge of DFMEA and PFMEA
Working knowledge of DFA / DFM principles
Project management skills.
Process verification and validation knowledge.
Lean manufacturing/Six Sigma concepts and understanding.


Skills/Competencies:
Results driven.
Self-directed with the ability to develop, facilitate and gain consensus in a team environment.
Effective communication skills with superiors, subordinates, and contractors.


Other Skills:
Ability to adapt to evolving projects requirements.
Problem solving skills.
Demonstrate flexibility, adaptability and integrity when making decisions. International travel required. (Approximately 25%)


ORGANIZATIONAL RELATIONSHIPS/SCOPE:
This position is an individual contributor position with project leadership and oversight responsibility.
The position reports to the Operations Commercialization Engineering Director, located in North Haven, CT, USA.


WORKING CONDITIONS:
Normal Office conditions, with time spent working on manufacturing shop floors.

DISCLAIMER:
The above statements are intended to describe the general nature and level of work being performed by employees assigned to this classification. They are not intended to be construed as an exhaustive list of all responsibilities, duties and skills required of employees assigned to this position.