Scanlan International is seeking a Manufacturing Engineer with metallurgy background. This is a unique and yet challenging engineer position as you will be responsible for the coordination and control of all aspects regarding the manufacture of surgical instruments. The ideal person knows metal alloys and the process to produce a product from this knowledge. This position will interface with R&D, Continuation Engineering, Manufacturing Support, and of course QA & Regulatory. You will become an "internal expert" who understands everything about the manufacturing process to allow us to continuing making state-of-the-art instruments.
Scanlan is a family owned business located south of downtown St. Paul. We have a culture of collaboration, respect and a desire to design and build quality products for our customers.
Continue to read more and if interested please submit your resume to BamlettC@Scanlangroup.com
ESSENTIAL DUTIES & ACCOUNTABILITIES
R&D and Continuation Engineering Project Coordination:
- Coordinates design transfer activities to support transition from R&D to manufacturing.
- Coordinates design tests to verify and validate design.
- Coordinates design of tooling, fixtures, and packaging to aid in the supplier build and assembly processes and ensure safe transport.
- Develops equipment and process validation requirements (Process FMEA, IQ, OQ, PQ).
- Provides engineering support to manufacturing.
- Reviews production schedules and supports product acceptance activities.
- Uses statistical tools to analyze data, make acceptance decisions, and improve process capability.
- Provide technical review and assessment when qualifying new suppliers.
- Develop and validate new manufacturing processes working with external suppliers
- Provide engineering support in the troubleshooting of process or product issues, including root cause failure analysis of discrepant materials and assemblies, including CAPA activities.
- Promote and lead Lean Manufacturing and Continuous Improvement activities in Manufacturing.
- Determines process improvements to improve product quality.
- Generates internal quality documentation such as quality plans, SOPs and inspection procedures.
- Provides all planning necessary to ensure effective product acceptance based on Device Master Record.
- Assists in monitoring field quality issues and analyzing field returns.
- Performs data analysis and investigations. Tracks quality trends and initiates action items to resolve issues.
- Participates in internal and external quality audits.
Ensure QA, FDA and ISO compliance in all areas of responsibilities.
JOB SPECIFICATIONS / QUALIFICATIONS:
- B.S. degree in an Engineering discipline.
- 5 years of related experience in Certified ISO 13485 medical device industry.
- Detailed knowledge of ISO 13485 and the FDA 21 CFR, Part 820, Quality System Regulation.
- Experience in managing/coordinating engineering activities.
- Experience with physical metallurgy or implantable devices.
- Experience using CAD and Solid Works
- Experience with ERP systems.
- Strong analytical and technical skills required
- Statistical Process Control (SPC) Implementation experience
- Ability to read and interpret drawing specifications
- Proficient in the Microsoft (MS) Office Suite of Products
- Strong oral and written communication skills
- Ability to write technical reports, business correspondence, technical and administrative procedures.
- Strong team player that works well with all levels of Associates collaboratively and respectfully in a team environment.