Job Title: Engineer Senior, Drug Delivery Medical Device (JP9612) Location: Thousand Oaks, CA. Employment Type: Contract Business Unit: FPT Development Product Engineering Duration: 1+ years (with likely extensions and/or conversion to permanent) Posting Date: 1/3/2022 3 Key Consulting is hiring a Senior Engineerfor a consulting engagement with our direct client, a leading global biopharmaceutical company. Job Description: Lead teams in the development of drug delivery devices. Scope includes a wide range of devices, such as needle protection systems, fluid transfer devices, pen injectors, automatic pen injectors, and micro-infuser delivery pump systems. The qualified candidate will lead technical teams to ensure successful device development of these mechanical and electro-mechanical medical devices. The Senior Engineer will work closely with team members to develop detailed engineering specifications, device design & development, support verification, validation, and regulatory submissions of these devices. The role of the Senior Engineer is to work within a cross-functional organization to utilize technologies and methodologies that support short-cycle robust device development. Responsibilities include: Work cross-functionally with individuals and project teams in Marketing, Operations, and Development. Create and assess product requirements to determine technical coverage and proper integration different subsystems. Create and execute to project plans and schedules. Develop, execute, and review architecture documents, design documents, specifications, development plans, characterization plan, verification and validation plans and other related product development documents for assigned projects. Provide deep technical assistance for junior engineers. Why is the Position Open? Planned project. Top Must Have Skills: Design controls. Mechanical testing. Drug delivery experience. Risk base process. Presentation skills. Day to Day Responsibilities: Author device documentation to support development, planning, verification, validation, and transfer. Author test protocols and execute mechanical testing of drug delivery devices. Presentation and communication skills (within program teams). Execute and deliver within regulated development processes. Proactively maintains close communication with technical leads. Basic Qualifications: BS in Engineering and previous experience in a medical device industry. 10 years’ current experience with engineering processes and procedures. Led projects from development through the 510k and PMA approval process. Strong background in engineering and commercialization of electro-mechanical medical devices. Experience with material & test specs generation, protocol & report writing, process & test development, prototyping, design verification, DOE/SPC process optimization & validation (IQ, OQ, PQ), FMEA. Product design/development (design control) from concept to post product launch for Europe (EMEA/CE Mark) & US (FDA/PMA/510k) submissions. Experience in drug/device combination product design and development. Familiar with the following standards: Quality System Regulation.
...throughout San Diego County Referral bonus Up to $30 per hour with overtime Job Description Summary Personal Care Attendant-Caregivers provide non-medical service and assistance to a client in their home and communities, who, because of advanced age or physical or...
...relationships that motivate us all every day. Join us today, and experience a career well lived.\n Pay $21.00 per hour! Part-time every other weekend position available. \n THRIVE AS A CAREGIVER / DIRECT SUPPORT PROFESSIONAL AT SEVITA. EACH DAY, YOU'LL \n \...
...Our client a well known Financial Services Firm is seeking a Financial Content Writer in their New York, New York Location! Key Responsibilities: Develop and write high-quality content and marketing assets (articles, blog posts, white papers, etc.) Generate topical...
Setting: Hospital We're hiring a licensed pharmacist for a contract position where youll use your clinical expertise to ensure the safe and thoughtful distribution of medications to individuals navigating a range of physical and mental health challenges.Apply...
...HR Generalist (HRG) Primary Tasks and Responsibilities: The HRG is responsible for leading and executing the client's group of businesses HR strategies, policies, and practices. This role oversees recruitment, employee relations, benefits administration, performance...