Peter Seiler Email & Phone Number

Kalamazoo, Mi, Us

Kalamazoo, Mi, Us

Devleopment of special processes for orthopedic implants. Activities include:1) Integration and development of biological evaluation process for orthopedic implants and instruments. 2) Working with suppliers to identify and mitigate biological hazards associated with medical device manufacturing processes. 3) Conducting biolgical evaluation risk assessements. 4) Working with testing labs to develop biological evaluation testing programs. 5) Training appropriate personel on requirements of ISO 10993-1 Biological evaluation of medical devices. 6) Development of specifications and acceptance criteria for the qualification and monitoring of final cleaning processes.

Minneapolis, Mn, Us

o Contributions: Process validation, component qualification, root cause investigations and process optimization for safety and ergonomics. These activities supported the supply of critical components for implantable medical devices. o Results: 1) Process and component qualifications resulted in higher levels of component compliance and process capability. 2) Root cause investigations resulted in lower levels of waste (material and time). Process Optimization activities resulted in higher levels of compliance with regards to worker safety and ergonomics. o Skill Sets: Project management, materials science, process development, six-sigma, statistical analysis, technical writing, analytical chemistry, root cause investigations and biocompatibility.

Minneapolis, Mn, Us

o Contributions: 1) Served as materials engineer for several product development projects that included leads and catheters. 2) Development of implantable drug delivery device for infection prevention. 3) Regulatory support for PMA and 510K submissions. 4) CAPA, RPI (Returned Product Investigations) and Root Cause Analysis. o Results: 1) Successful introduction of three new products (Attain Performa™, Attain Command II + SureValve™, Attain Select II + SureValve™. Successful clinical trial for a drug delivery catheter. 2) One patent filed and three patents pending for implantable infection prevention devices. 3) FDA approval for several new products. 4) Determine root cause of device failure during in use conditions. o Skill Sets: Project management, materials science, materials selection, biocompatibility, biostability, test method development, materials testing statistical analysis, technical writing, analytical chemistry, root cause investigations, documentation for regulatory submissions, creative thinking, and negotiating.

Masters in Manufacturing Systems from University of St Thomas

St Paul, Mn, Us

o Contributions: Served as product development engineer for several medical, drug delivery and dental product development projects. o Results: 1) New product introductions for wound care Clear Absorbent Tegaderm™ and HP Tegaderm™. 2) Improved skin adhesive for Red Dot Electrodes™. 3) Proof of feasibility for transdermal drug delivery patch resulting in increased lab revenues. 4) Scale transfer of chemical process (excipients used in inhalation delivery). o Tools and Skill Sets: House of quality, formulation chemistry, six sigma, design controls, formulation design, statistical analysis, test method development, polymer synthesis, process development, DOE.

Bachelor Of Science - Bs, Chemistry

Msms, Manufacturing

Masters Of Science, Manufacturing Systems Engineering

Bs, Chemistry