Manufacturing Engineer II

About CooperSurgical

CooperSurgical is a leading fertility and womens healthcare company dedicated to putting time on the side of women babies and families at the healthcare moments that matter most in life. As a division of CooperCompanies were driven by a unified purpose to enable patients to experience lifes beautiful moments. Guided by our shared values dedicated innovative friendly partners and do the right thing our offerings support patients throughout their lifetimes from contraception to fertility and birth solutions to womens and family care and beyond. We currently offer over 600 clinically relevant medical devices to healthcare providers including testing and treatment options as well as an innovative suite of assisted reproductive technology and genomic testing solutions. Learn more at.

Work location: North Tonawanda NY (on-site)

Scope:

The Manufacturing Engineer II is responsible for optimizing manufacturing processes and ensuring the production of high-quality 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.

1. Serve as the manufacturing transfer core-team member on integrations of new product acquisitions
2. Design and development of efficient manufacturing processes for medical device products with a focus on quality cost-effectiveness and scalability.
3. Optimize existing manufacturing processes to improve efficiency yield and productivity while maintaining compliance with regulatory and quality standards often using lean manufacturing techniques.
4. Conduct process validations process capability studies and root cause analyses to identify and resolve manufacturing issues implementing corrective actions as needed.
5. Assist in the development of project plans and proposals that include elements such as Gantt charts cost-benefit analysis risk assessments and regulatory strategies.
6. Collaborate with R&D teams to ensure new products are designed for manufacturability considering assembly methods equipment selection and process validation requirements.
7. Contribute to the fostering of a culture of knowledge sharing and professional development.
8. Develop and maintain manufacturing documentation including work instructions standard operating procedures and process control plans ensuring compliance with regulatory requirements.
9. Support the manufacturing floor via partnering with maintenance engineers and technicians to resolve day-to-day downtime.
10. Ownership review and management of Standard operating procedures PFMEA and Control Plan process and all related documentation documents.

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. 10-20% travel is expected.

• Bachelors degree in mechanical engineering Industrial Engineering or a related field.
• 2-5 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
  • 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 problem-solving skills and the ability to work effectively in a cross-functional 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:

• Working knowledge of 21 CFR Parts 210 211 and 820 within a combination product environment with a solid understanding of FDA expectations

• 2-5 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:
  • Electronics
  • Automation

  • Assembly

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 via-email 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 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.

For U.S. locations that require disclosure of compensation the starting base payfor this role is between$75000.00 - $100000.00 annually. Theactual base payincludes many factors and is subject to change and modification in the future. This position may also be eligible for other types of compensation and benefits.