Teddy Damen Email & Phone Number

Medemblik, Nh, Nl

Enkhuizen, Noord-Holland, Nederland

Medemblik, Noord-Holland, Nederland

Consultant for design and engineering activities in a variety of fields (medical devices, food packaging).

• Defining the usability engineering strategy for new product developments• Design of formative and summative usability studies (protocols, reports)

• Formulating design inputs (requirements), while reviewing and searching forapplicable standards.• Development of test protocols, including test method validations (TMV) for designverification and validation activities. Responsible for choosing the appropriatesample size per test case, and the overall sampling plan strategy of the verificationand validation activities to minimize the amount of samples required.• Development, and reviewing of technical drawings of product components andtest/manufacturing equipment in SolidWorks.• Lead engineer on the shipment, shelf life, and sterile barrier validation activities:managing a test location in the development of protocols and reports.• Responsible for the root cause investigation of packaging validation failures onsterile barrier systems, and decreased manufacturing capability on infusion sets.• Technical review lead on process validation documentation (e.g. processcharacterization, DOE, TMVs, IQ, OQ, PQ).

Utrecht En Omgeving, Nederland

• Establishment of ISO 13485 and 21 CFR 820 compliant QMS processes (e.g. designcontrol, usability engineering, packaging & labelling)• Completing the Design History File for a class IIb medical device (insulin infusionpump);• Participation in risk management activities: technical review on the design/manufacturing/usability FMEAs, ensuring full traceability between risk mitigationsand the design outputs.• Development of packaging & labelling specifications compliant to the new MDRincluding the unique device identification (UDI) system to the products;

Den Haag En Omgeving, Nederland

• Actively involved in 2 successful CE and FDA (510k) product submissions for a classIIa medical device for positional sleep apnea therapy;• Writing technical documentation (specifications, technical drawings, verificationand validation plans, protocols and reports) to support regulatory compliance;• Lead on human factors engineering: design and validation of user manuals, mobileapp and web-platform for patient data, and product functionalities;• Performing design verification & validation activities;• Managing 3rd party suppliers to deliver according to the project plans;• Collaboration to obtaining ISO 13485 accreditation for the company and successfulFDA inspection.

Rotterdam En Omgeving, Nederland

Hoorn

Master Of Science (Msc), Integrated Product Design

Graduated on the design of a combined treatment solution for positional obstructive sleep apnea. Final grade: 9.

Bachelor Of Science (Bsc), Industrieel Ontwerpen (Industrial Design) / Industrieel Product Ontwerpen

Minor: Interactive Environments