DescriptionThe Manufacturing Engineer II is responsible for optimizing manufacturing processes and ensuring the production of highquality medical devices. The Manufacturing Engineer II will directly contribute to continuous improvement initiatives and integration projects that reduce costs and increase the quality of CooperSurgicals manufacturing processes. The Manufacturing Engineer II is expected to have strong partnerships with the production quality product engineering and regulatory departments.
Job Summary:
The Manufacturing Engineer II at CooperSurgical is responsible for driving manufacturing excellence and optimizing production processes for our medical device and fertility products. The Manufacturing Engineer II plays a critical role in driving integration projects implementing lean principles improving process efficiency and fostering a culture of continuous improvement.
Responsibilities- Serve as the manufacturing transfer coreteam member on integrations of new product acquisitions
- Design and development of efficient manufacturing processes for medical device products with a focus on quality costeffectiveness and scalability.
- Optimize existing manufacturing processes to improve efficiency yield and productivity while maintaining compliance with regulatory and quality standards often using lean manufacturing techniques.
- Conduct process validations process capability studies and root cause analyses to identify and resolve manufacturing issues implementing corrective actions as needed.
- Assist in the development of project plans and proposals that include elements such as Gantt charts costbenefit analysis risk assessments and regulatory strategies.
- Collaborate with R&D teams to ensure new products are designed for manufacturability considering assembly methods equipment selection and process validation requirements.
- Contribute to the fostering of a culture of knowledge sharing and professional development.
- Develop and maintain manufacturing documentation including work instructions standard operating procedures and process control plans ensuring compliance with regulatory requirements.
- Support the manufacturing floor via partnering with maintenance engineers and technicians to resolve daytoday downtime.
Coopers management team is committed to the development of and implementation of the quality management system and maintaining its effectiveness by communicating to the organization the importance of meeting customer as well as statutory andregulatory requirements.
Travel:
- Travel may be required to attend meetings or visit manufacturing sites. Approx. 1020% travel is expected.
Qualifications- Bachelors degree in mechanical engineering Industrial Engineering or a related field.
- 25 years of experience in manufacturing engineering within the medical device or pharmaceutical industry.
- Intermediate knowledge of medical device manufacturing processes. Experience in any of the following desired:
- Injection molding and/or Extrusion
- Electronics
- Automation
- Strong computer skills with the ability to use Excel Word PowerPoint and Visio. Advanced skills preferred.
- Proficiency in Lean Six Sigma concepts statistical analysis tools (e.g. Minitab) and root cause analysis.
- Excellent problemsolving skills and the ability to work effectively in a crossfunctional team environment.
- Knowledge of quality and regulatory requirements such as ISO 13485 FDA QSR EU MDR and GMP.
- Strong project management skills with the ability to prioritize tasks and manage multiple projects simultaneously.
- Excellent communication skills both verbal and written with the ability to convey complex technical information to diverse audiences.
Work Environment:
- Occasional lifting of up to 35 kilograms may be required.
- Prolonged sitting in front of a computer is common.
- Ability to work in uncomfortable positions when required. For example when repairing various manufacturing equipment.
Experience:
- 25 years of experience in manufacturing engineering within the medical device or pharmaceutical industry.
- Intermediate knowledge of medical device manufacturing processes. Experience in any of the following desired:
- Injection molding and/or Extrusion
- Electronics
- Automation
Education:
- Bachelors degree in mechanical engineering Industrial Engineering or a related field.
- Lean Six Sigma Certification
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Our Benefits:
As an employee of CooperSurgical youll receive an outstanding total compensation plan. As we believe your compensation goes beyond your paycheck we offer a great compensation package medical coverage 401(k) parental leave fertility benefits paid time off for vacation personal sick and holidays and multiple other perks and benefits. Please visit us atto learn more about CooperSurgical and the benefits of becoming a member of our team.
To all agencies: Please no phone calls or emails to any employee of CooperSurgical about this opening. All resumes submitted by search firms/employment agencies to any employee at CooperSurgical viaemail the internet or in any form and/or method will be deemed the sole property of CooperSurgical unless such search firms/employment agencies were engaged by CooperSurgical for this position and a valid agreement with CooperSurgical is in place. In the event a candidate who was submitted outside of the CooperSurgical agency engagement process is hired no fee or payment of any kind will be paid.
We are committed to equal employment opportunity regardless of race color ancestry religion sex national origin sexual orientation age citizenship marital status disability gender gender identity or expression or veteran status. We are proud to be an equal opportunity workplace.