Rick Rasmussen Email & Phone Number

Cary, Nc, Us

Richmond, Virginia, Us

Raleigh, Nc, Us

• Lead and collaborate on company strategy and culture initiatives as a member of the company executive leadership team.• Develop and execute a medical device quality system adhering to standards and regulations including FDA 21 CFR 820, ISO 13485, ISO 14971, and ISO 62304.• Responsible for strategic planning of a quality system for a Class III IDE cardiovascular device.• Lead the development and maintenance of the design history file and have primary responsibility for the design control process.• Guide and mentor a team of engineers and quality professionals.• Coordinate multiple contract manufacturers to a create comprehensive plan for kitting and distributing devices for clinical trials.• Plan and prepare IDE pre-submissions as well as interface with FDA on development strategy.• Negotiate with contract manufacturers to ensure requirements for product quality, cost, and availability are met.

Raleigh, Nc, Us

• Implemented a comprehensive quality system for a clinical-stage medical device company.• Established the company’s design control procedure and developed the design history file.• Created policies and procedures for design control, risk management, usability, and manufacturing.• Provided quality leadership during a clinical trial for a Class III IDE device, including device traceability, establishment of manufacturing records, and logistics associated with distribution and returns.• Initiated critical quality systems such as internal audits, CAPAs, complaints, and equipment management.• Sourced and implemented an electronic QMS system to replace paper-based systems.• Performed regular training of staff in quality system and product development best practices.

Wayne, Pa, Us

• Lead product development efforts for surgical devices according to ISO 13485 and 21 CFR 820. • Provide guidance and training for best practices in design control, statistical analysis, and risk management.• Develop verification and validation test protocols for benchtop and in-vivo studies. Develop test methods, supervise testing, and perform analysis of results.• Translate customer requirements into design specifications.• Present quality deliverables for stage-gating process with accountability for their successful completion.• Define objectives, write protocols, and lead formative and summative animal studies to cultivate user needs of surgical devices.• Serve as business unit usability SME and lead usability validation labs to assess device performance with surgeons according to IEC 62366 and ANSI/AAMI HE-75.• Lead data collection and user engagement in summative usability studies to validate the design and evaluate human factors engineering of surgical devices.• Provide on-site support for manufacturing operations in Mexico and Germany to establish project alignment and build relationships with international colleagues and suppliers. • Key member of global team responsible for harmonizing design and development, risk management, and manufacturing SOPs across multiple sites.• Lead cross-functional teams to develop global policies and processes for new product development.• Mentor, train and develop junior engineers.

• Provided quality engineering expertise for the surgical product development team• Acquired and developed customer needs through surgeon interviews and pre-clinical labs. Facilitated translation of the customer needs into design inputs.• Provided technical expertise for due diligence as part of acquisition of micro laparoscopic product line.• Led risk management team in the development of new products. Responsible for Hazards Analysis, DFMEA and risk management documentation.• Serve as product expert for field corrective actions or supplier corrective actions, including providing risk analyses as well as troubleshooting and root cause analysis for CAPA completion.• Led the qualification of new injection molded components from multiple vendors. Analyze inspection data and collaborate on scheduling of component qualification processes.

Developed processes and write SOPs for quality assurance, equipment control, and plasma collection operations used in over 60 plasma collection centers across the country.

• Third full time employee of a medical device start-up responsible for the development of surgical instruments. • Responsible for implementation of the company’s quality system. Worked with consultants to create SOPs for design control, complaint management, CAPAs, and verification and validation.• Led implementation of Agile PLM system. Defined requirements and collaborated with consulting company throughout implementation• Led incoming inspection, in-process manufacturing inspection, and product release.• Raised $21M in Series A venture capital funding. Achievement of development milestones resulted in $55M in Series B financing.• Initiated and led over 90 formative animal studies. Recruited surgeons and provided training for single-port surgery. Engaged in post-lab interviews with participating surgeons to deliver design inputs to R&D team.• Presented quality goals and metrics investors and board of directors• Developed processes for gathering, storing, and tracking customer needs. Translated the customer needs from the animal and human cases into design inputs for product design.• Instrumental in the domestic and international project management for the successful completion of seven first-ion-man cases in South America.• Hired and collaborated with multiple consultants for the development of quality assurance and manufacturing processes.• Responsible for leading, developing, and training a Quality Control Inspector.

Master Of Business Administration, Marketing Management

Environmental Science/Political Science