Job Summary
- Location
- Brooklyn Park, MN 55429
- Industries
- Manufacturing - Other
- Medical Devices and Supplies
- Job Type
- Full Time
- Employee
- Years of Experience
- 7+ to 10 Years
- Career Level
- Experienced (Non-Manager)
- Job Reference Code
- 3931
Design Quality Engineer
About the Job
Accellent, Inc. is a fully integrated provider of design, supply chain management and strategic sourcing services to the Medical Device industry. Accellent www.accellent.com, a recognized market leader, is a fast-growing outsource manufacturing and design solution company specializing in high growth areas such as Cardiology, Endoscopy and Orthopaedics. The top Medical Device companies partner with Accellent to provide innovation, advanced technology, speed to market, low cost labor and strategic sourcing.
We’re looking for team players with a can-do attitude to share in our vision and corporate values. Accellent offers competitive salaries; a comprehensive benefits package, and a stimulating work environment.
We’re looking for team players with a can-do attitude to share in our vision and corporate values. Accellent offers competitive salaries; a comprehensive benefits package, and a stimulating work environment.
Currently, we are searching for a Design Quality Engineer to join our Brooklyn Park, MN facility.
Position Scope / Summary
Quality assists in the design and implementation of policies and procedures for testing and evaluating the precision and accuracy of products and/or equipment. The Design Quality Engineer will be expected to provide QE leadership, interact with customers and provide support to Operations and Manufacturing / Design and Development Engineering.
Specializations may include but are not limited to: design control; material and process control; product reliability; software quality engineering; and/or metrology.
This position will be integral in meeting the Quality Management System requirements. It requires creativity and foresight to work with operations and product development teams to ensure compliance to the Quality Manual, Design Control, Supplier Management and other appropriate procedures for a variety of medical devices from concept through market introduction. The ideal candidate is a self-motivated individual who is excited by the prospect of working in a dynamic, fast-paced environment.
Key Result Accountabilities
- Manage company compliance with FDA Quality System Regulations and ISO 13485 standards. Experience with FDA and ISO inspections and registration is preferred.
- Lead internal audits, management review and other activities covered under Accellent Quality Manual, Policies and Procedures.
- Indirect Regulatory Affairs activities which include but are not limited to providing support for customer-related quality and regulatory inquiries.
- Compiles and writes training material and conducts training sessions on Quality Engineering activities.
- Provide QE direction, analysis and recommendations for Product Development to successfully launch new products into active production in a timely and cost effective manner.
- Directs development and maintenance of internal/external standards relative to Design and Development. Design for Manufacturing and Six Sigma experience is a plus.
- Manage implementation of design and development projects or act as subject matter expert for SPC, FMEA, DOE, design verification/validation and process validation.
- Perform Project Management as needed.
- Develops and initiates standard methods for inspection, testing, and evaluation, utilizing knowledge in related engineering fields. Knowledge of medical device product testing such as packaging integrity, product bioburden, biocompatibility, distribution and stability testing is a plus.
- Devises sampling procedures and designs and develops forms and instructions for recording, evaluating, and reporting quality and reliability data.
- Performs measurement system analyses to evaluate test and inspection equipment.
- Leads disposition of discrepant material and devises process to assess product quality and reliability.
- Monitors and directs engineering group on calibration requirements and implementation of systems to support equipment calibration.
- Directs workers engaged in measuring, testing, and tabulating data concerning quality and reliability.
- Manage supplier approval and qualification of new/revised items which includes inspection method development and validation as well as correlation with supplier’s methods, supplier audits, management of supplier corrective and preventative actions and assist in FMEA.
- Direct support for FDA and ISO inspections and registration.
- All other duties as assigned.
- Up to 20% travel may be required.
Job Requirements:
Qualifications
- 8+ years experience in the Medical Device or other regulated industry, such as QSR and ISO 13485, with increasing responsibility. Finished device experience is a plus.
- Indirect experience with FDA and ISO 13485 Certification inspections and other regulatory requirements such as FDA submissions, Design History Files, Technical Files and International Dossiers is a plus.
- 5 years plus Project management experience, supervising diverse teams.
- Must be adept in use of computer systems for the analysis of data, specifically Microsoft office and Statistical packages (Minitab preferred).
- Validation experience required
- Plastic Injection Molding and/or Plastic Extrusion experience
- Quality Engineering certification (CQE) and/or Regulatory Affairs Certification (RAC) or equivalent body of knowledge in areas which include, but are not limited to Statistics, SPC, Geometric Dimensioning/Tolerancing; Sampling, Design of Experiments etc. Ability to analyze, understand and effectively communicate this technical material.
- Experience with Lean Manufacturing and Six Sigma is required, preferably both Black Belt & DFSS.
- Ability to organize and judge priorities in a dynamic, fast-paced environment and work independently with minimal supervision.
- Must possess excellent verbal & written communication skills which include but are not limited to presentation, organizational and management skills.
- Typical number of employees in organization is 6.
Accellent is an Equal Opportunity/Affirmative Action employer and we value diversity in our workforce. As such we provide equal opportunity for all applicants without regard to race, religion, gender, national origin, age, marital status, veteran status, or disability. To learn more about Accellent and our career opportunities, please visit us at www.accellent.com
Req. Code : 3931
% of Travel Required : 20-30%
Shift/Hours : First Shift (Day)
