Manufacturing Engineer I

CooperCompanies•North Tonawanda, NY

11h•Onsite

About The Position

The Manufacturing Engineer I is responsible for optimizing manufacturing processes and ensuring the production of high-quality Combo Pharma/medical devices. The Manufacturing Engineer I will primarily contribute to sustaining activities, as well as continuous improvement initiatives that reduce costs and increase the quality of CooperSurgical’s manufacturing processes. The Manufacturing Engineer I is expected to have strong partnerships with the production, quality, product engineering, and regulatory departments. The Manufacturing Engineer I at CooperSurgical is responsible for driving manufacturing excellence and optimizing production processes for our medical device and fertility products. The Manufacturing Engineer I plays a critical role in implementing lean principles, improving process efficiency, and fostering a culture of continuous improvement.

Requirements

Bachelor’s degree in mechanical engineering, Industrial Engineering, or a related field.
0-3 years of experience in manufacturing engineering within the medical device or pharmaceutical industry.
Introductory knowledge of medical device manufacturing processes.
Strong computer skills with the ability to use Excel, Word, PowerPoint, and Visio.
Awareness of 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.
Introductory knowledge of quality and regulatory requirements, such as ISO 13485, FDA QSR, EU MDR and GMP.
Proficient 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.
Knowledge of 21 CFR Parts 210, 211, and 820 within a combination product environment, with an understanding of FDA expectations.
0-3 years of experience in manufacturing engineering within the medical device or pharmaceutical industry.

Nice To Haves

Advanced skills preferred (for computer skills).
Travel may be required to attend meetings or visit manufacturing sites. Approx. 10-20% travel is expected.

Responsibilities

Sustaining manufacturing activities such as executing change orders for existing products and processes, investigating non-conformances in the product and process, and supporting maintenance and calibration technicians.
Design and development of efficient manufacturing processes for medical device products, with a focus on quality, cost-effectiveness, 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, cost-benefit 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 day-to-day downtime.
Cooper’s 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 and regulatory requirements.