Scanlan International is seeking a Product Design Engineer II to join their R&D team to help develop new and innovative surgical instruments and other medical device products. There are so many great aspects to this position, such as, cross functional project management, product development leadership from concept to commercialization and expanding their current design experience into full medical device product development. There are multiple development programs going on simultaneously and this person would have an opportunity to both be a leader of their own projects and contribute to other projects.
The Product Design Engineer is responsible for developing novel products for use in cardiovascular, thoracic, neurovascular and other surgical procedure. This person will also be responsible for design/re-design of existing surgical instruments, managing CAD system, preparing/reviewing drawings, materials and manufacturing, quality control, maintaining design history files, and creation of all R&D documentation, technical assistance, and other tasks as required.
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.
ESSENTIAL DUTIES & ACCOUNTABILITIES
- Develop new product concepts following specific Design Control procedures per ISO and FDA utilizing processes.
- Establish product requirements and specifications for these products
- Coordinate Product Development team to support any new/re-design products.
- Author and coordinate Risk Management activities.
- Meet with and review potential/current suppliers to assess capabilities, etc.
- Create test protocols and acceptance criteria including Product Validation testing. Perform testing and document results for final approval.
- Research new product technologies for review/discussion.
- Prepare/Review drawings for engineering, production and quality control as requested.
- Train and assign work direction to any outside suppliers with drawing generation.
- Prepare/Review drawings of existing products to document product specifications as requested.
- Direct necessary changes to improve drawing completeness.
- Assist Instrument Department with necessary information, details, tolerances, etc. for drawing completeness.
- Define manufacturing protocols and materials specifications.
- Coordinate prototyping and evaluation of new product designs.
- Design/Develop/Document Fixtures to aid in assembly and production.
- Investigate product complaints and make recommendations for final determination and corrective action.
- Create formal process documentation such as QSP’s, Work Instructions (WI), Inspection Procedures (IP), Manufacturing Procedures (MP), forms, etc. and get final approvals.
- Create and maintain records and files that comply with cGMP and ISO requirements such as Device Master Record (DMR), Device History File (DHF), Design History Record (DHR) and Technical Construction Files (TCF).
SPECIFICATIONS / QUALIFICATIONS:
- Minimum of 4 year technical degree (BS/ME preferred) or similar work experience required.
- Minimum 3-5 years work experience as a Product Designer utilizing design control procedures with medical devices (in an ISO certified company) required.
- Minimum 3-5 years experience with 2D and 3D solid modeling software (AutoCAD, SolidWorks) required.
- Experience writing documentation supporting the Quality Systems, WI, forms, etc., in an ISO certified medical device company strongly preferred.