Design Control Engineer 1

1 week ago

Bloomington, United States Cook Group Full time

Overview:

Maintain and refine Cook Incorporated Design Controls quality system policies and procedures, ensuring that they meet the needs of stakeholders and the expectations of regulators. Additionally, provide guidance to Manufacturing and Post-Market Engineering and other departments that interface with Design Controls activities.

Responsibilities:

- Work with Manufacturing and Post-Market Engineering, Risk Management, and other stakeholders to maintain and refine policies and procedures for Design Controls.
- Develop and maintain an understanding of applicable standards, regulations, and guidance documents that affect Design Controls.
- Help support Cook Incorporated in internal / external audits and assist with audit responses / CAPAs. Monitor Design Controls CAPAs and internal / external audit feedback from the manufacturing operations quality systems and evaluate impacts to policies and procedures.
- Participate in the development and deployment of training for Design Controls.
- Coordinate and conduct training for Design Controls.
- Drive consistency across Cook Incorporated in the approach to Design Controls.
- Within scope of responsibility, ensure all quality, regulatory, compliance, and product-specific requirements are met.
- Adhere to the Quality Management System and its processes to meet FDA 21 CFR 820, ISO 13485, and other applicable regulatory requirements.
- Must maintain all training requirements for the position, while seeking out opportunities for continuous development and growth.
- Experience in developing and managing policies and procedures is preferred, but not required.

- Must work and interact effectively and professionally with and for others throughout various levels of the global organization.
- Must strictly adhere to safety requirements.
- Maintain regular and punctual attendance.
- Must maintain company quality and quantity standards.
- Must have effective communication skills and ability to work in a collaborative and independent work situations and environments with
minimal supervision.
- Ability to remain calm and receptive in fast paced situations.

Qualifications:

- BS in Engineering, preferably in Mechanical or Biomedical.
- 2 years experience in the Medical Device industry is preferred, but not required.
- Experience in developing and managing policies and procedures is preferred, but not required.

Physical Requirements:

- Works under general office environmental conditions.
- Sitting for extended periods, utilizes close visual acuity for working with computers, equipment, etc.
- Frequently required to sit, stand, walk, and communicate.
- Must be able to perform the essential functions of the job, with or without reasonable accommodations.
- Occasionally required to lift up to 20 pounds.

- Must be able to perform the essential functions of the job, subject to reasonable accommodation requirements under the ADA.

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