job summary: An Engineer is needed for a multinational biotechnology company that specializes in the discovery, development, and delivery of therapies for the treatment of neurodegenerative, hematologic, and autoimmune diseases to patients worldwide. Remote work. Candidate should have a BS in Biomedical/Mechanical Engineering or related technical or scientific disciple and 6-8 years of working experience in medical device and/or combination product function within a medical device, biotech, or pharmaceutical company. location: Remote, Remote job type: Contract salary: $59.85 - 84.50 per hour work hours: 8am to 5pm education: Bachelors responsibilities: Mature experience in medical device/combination product design and developmentLead Quality Engineering guidance and oversight for medical device and combination products during all phases of design control, risk management, human factor/usability engineering, process development and verification/validation testing, and potentially lifecycle management during design changes.Assist device development team to define critical to quality characteristics for device components and finished devices.Assist with Quality review and approval of technical documentation for design and development technical and risk management documentation, e.g., planning, traceability matrix, protocols, reports, risk assessments, testing, etc. through applying applicable company procedures and regulatory requirements.Escalate program and Quality concerns to Device Development Quality management.Provide input to process manufacturing design and design transfer to ensure compliant, robust product realization.Support the timely handling of investigations, impact assessment, deviations, and CAPAs, and technical matters (i.e. design changes, verification and validation) with impact to design control and risk management or related supply chain operations. Technical Skills and Experience: Experience in medical device design and development technical oversight and related risk assessment and management throughout the product lifecycleQuality oversight experience of device and/or combination product processes and documentationWorking knowledge and application of device regulations, including 21 CFR 820, 2017/745, 21 CFR Part 4, ISO 13485, ISO 14971 and ICH Q9, ISO 11608, ISO 62366, ISO 10993.Experience in supplier management and relations, including quality agreement generation and maintenance.Working knowledge of process development and validation principlesExperience in hazard analysis and application of risk analysis tools such as FMEA, Fishbone, etc.Experience with regulatory inspections and interaction with regulatory authoritiesExperience in Change Control Minimum of a BS in Biomedical/Mechanical Engineering or related technical or scientific disciple: A minimum of 6-8 years of working experience in medical device and/or combination product function within a medical device, biotech, or pharmaceutical company qualifications: Experience level: ExperiencedEducation: Bachelors skills: Mechanical EngineeringMedical Device Equal Opportunity Employer: Race, Color, Religion, Sex, Sexual Orientation, Gender Identity, National Origin, Age, Genetic Information, Disability, Protected Veteran Status, or any other legally protected group status. For certain assignments, Covid-19 vaccination and/or testing may be required by Randstad's client or applicable federal mandate, subject to approved medical or religious accommodations. Carefully review the job posting for details on vaccine/testing requirements or ask your Randstad representative for more information.