Job title: Manufacturing Engineer Duration: 1 Year Location: West Valley City, UT
Will this worker be part of a Special Project?
EUMDR
HM Notes: - Wants this candidate on site for executions and at the beginning. Then there will be opportunity for this worker to work remote a few days a week
Interview process - 1 onsite interview and site tour.
Summary The position will need to help execute gap assessments against EUMDR. So preferably candidates who are more familiar with that standard would be the preference. The individual should still have a strong validations background as well. After the gap assessment, the validations will take place.
Responsibilities:
Generation and execution of validation plans, validation protocols (IQ/OQ/PQ), and completion reports, with a major focus on Test Method Validation and EUMDR Validation Remediation of medical devices.
Provide statistical analysis of the date to support the reports.
Troubleshooting equipment/processes that do not perform as intended during validation runs. Recommend process/quality improvements as part of validation runs.
Evaluate, investigate and document non-conformances incidents and/or protocol deviations. Complete assigned Non-Conformance and CAPA investigations and prepare investigation reports. Develops and maintains an effective cross-functional working relationship with plant and corporate Manufacturing, Engineering, Regulatory, and Quality Assurance personnel.
Work on project teams with other internal departments, external vendors, and customers as required. Assure that existing processes and assigned activities fully comply with regulatory and/or international agencies, such as FDA, ISO, OSHA, EPA, among others.
Participate in the compilation and review of technical documentation for both domestic and international regulatory submissions. Participate in external audits such as: FDA, Notified Body (BSI) and Corporate, among others. Performs other related duties as necessary.
Generate Gap Assessment for Design Files to EUMDR standard, including Validations, Labeling, Risk Files etc.
Participate in external audits such as: FDA, Notified Body (BSI) and Corporate, among others. Performs other related duties as necessary.
Qualifications:
Knowledge of FDA, OSHA, EPA, and GMP's and ISO requirements.
Knowledge in Organizational Excellence and Lean/Six Sigma.
Strong Project Management skills.
Ability to lead teams through complex projects and provide departmental technical leadership.
Must have excellent communication skills and a strong track record of working cross-functionally.
Must have demonstrated ability to think strategically. Able to develop technical documentation such as: Change Controls, Validation Plans, Validation Protocols, Technical / investigation reports, SOP, and others.
Teamwork oriented and self-starter.
Education and/or experience:
BS in Engineering, preferably Mechanical, Manufacturing, Industrial, Electrical, Chemical, or Biomedical (Professional Engineer License.) or sciences related field.
Lean/Six Sigma Green or Black Belt Certification is a plus.
Experience in validations such as: manufacturing equipment, manufacturing processes, Test
Method validation, stability or aging, required.
Minimum of 4-6 years of experience in the medical device and/or pharmaceutical manufacturing environment.
About Us: Established in 2004, SPECTRAFORCE® is one of the largest and fastest-growing diversity-owned staffing firms in the US. The growth of our company is a direct result of our global client service delivery model that is powered by our state-of-the-art A.I. proprietary talent acquisition platform, robust ISO 9001:2015/ISO 27001 certified processes, and strong and passionate client engaged teams. We have built our business by providing talent and project-based solutions, including Contingent, Permanent, and Statement of Work (SOW) services to over 140 clients in the US, Canada, Puerto Rico, Costa Rica, and India. Key industries that we service include Technology, Financial Services, Life Sciences, Healthcare, Telecom, Retail, Utilities and Transportation. SPECTRAFORCE is built on a concept of “human connection,” defined by our branding attitude of NEWJOBPHORIA®, which is the excitement of bringing joy and freedom to the work lifestyle so our people and clients can reach their highest potential. Learn more at: http://www.spectraforce.com
Benefits: SPECTRAFORCE offers ACA compliant health benefits as well as dental, vision, accident, critical illness, voluntary life, and hospital indemnity insurances to eligible employees. Additional benefits offered to eligible employees include commuter benefits, 401K plan with matching, and a referral bonus program. SPECTRAFORCE provides unpaid leave as well as paid sick leave when required by law.
Equal Opportunity Employer: SPECTRAFORCE is an equal opportunity employer and does not discriminate against any employee or applicant for employment because of race, religion, color, sex, national origin, age, sexual orientation, gender identity, genetic information, disability or veteran status, or any other category protected by applicable federal, state, or local laws. Please contact Human Resources at LOA@spectraforce.com if you require reasonable accommodation. At SPECTRAFORCE, we are committed to maintaining a workplace that ensures fair compensation and wage transparency in adherence with all applicable state and local laws. This position’s starting pay is: $48.00/hr.
