Live chat

Validation Engineer

Orchid Orthopedic Solutions - Memphis, TN

Validation Engineer

in

Memphis

Tennessee

SUMMARY OF POSITION

Working for a leading manufacturer of medical devices and registered with the FDA. The candidate who obtains this position will execute improvement activities; research, write, and execute validation protocols/activities for special processes and equipment for medical devices, assess validation impact for manufactured products at our facility pursuant to the appropriate Regulatory (FDA), customer requirement(s), and Self Certification documentation activities.

ESSENTIAL FUNCTIONS

Develops validation protocols, performs testing, and writes validation reports for various equipment manufacturing processes and products.

Responsibilities include:o Analysis of data, generation of reports and memos concerning above projects.

Provide recommendations based upon data.Determination of process capability of new equipment through execution of approved protocols and assures defined parameters are incorporated into respective operating procedures and other records.

Adheres to all company and cGMP procedures.

Participates in and provides input to new product / process team meetings.

Ensure current, relevant standards are adhered to for all processes.

Analyze data with Minitab

Use statistical rationale to determine process capability, sample size, high/low process parameters, and gage R&R; activities.

Maintains a safe and healthy work environment by following standards and procedures; complies with legal and ethical requirements.

Performs other related duties and tasks as required.

Perform other duties as required or directed by the Department Supervisor or Lead.

EDUCATION AND EXPERIENCE

Bachelor’s degree in biomedical, industrial or mechanical engineering field preferred

OR equivalent in years of experience and minimum of three to five years’ engineering and manufacturing experience, preferably in medical devices.

Should possess experience in validation of new and existing processes and equipment.

Should possess experience and knowledge of orthopedic implants and/or other medical devices.

Experience with Microsoft software products Excel, Word, Outlook, and PowerPoint is required.

Experience with Sterilization, Packaging, and Labeling preferred.

Experience in project leadership is preferred.

Experience participating in customer, vendor, and/or internal audits is a plus.

SKILLS & ABILITIES REQUIRED

3 years test / validation experience preferred

Statistical Analysis experience using Minitab (excellent analytical skills)

Medical device experience – highly preferred

Excellent written and oral skills

Must be proficient in interfacing within all levels of the organization

Must support Quality Assurance and Lean Manufacturing initiatives within the facility

Must be able to lead a small, technical team through validation exercises from protocol generation and execution through presentation to customers for approval.

Must be able to coach the organization in validation standards and be current on industry trends

Must be able to work in a fast paced environment with changing priorities.

Must adhere to Company Code of Conduct and Core Values.

PHYSICAL REQUIREMENTS

Corrected vision of 20/20, preferred.

Able to work in a fast-paced quality –oriented environment.

Use of Personal Protective Equipment (PPE) as determined for the position.

OTHER REQUIREMENTS

Must submit to and pass background and substance abuse tests.

Must be able to provide proof of eligibility to work in the United States through eVerify.

Must adhere to the Company Code of Conduct and Core Values.

Must follow designated safety rules and regulations.

Must be able to fulfill all the requirements of this position, including requirements related to the company’s Safety, Quality and Environmental Management System Policies and procedures.

To apply, please e-mail resumes to recruiting@orchid-ortho.com with the subject line: Application for Validation Engineer

Location:

Memphis TN

Apply Now

Apply Now

Share

11 days 3 hours ago

Orchid Orthopedic Solutions

Apply Now

Please review all application instructions before applying.

Location: Memphis, TN

Company Profile:
From our employees, to our customers, to the surgeons performing surgery and ultimately, to the patients that receive care using the products we make, we strive to affect people’s lives in a positive manner. We feel fortunate to be working in an industry that has the ability to impact lives in such a profound way and we are proud of the services we provide.