Job Title: Senior Engineer, Biotech Combination Products (JP11782C) Location: Cambridge, MA. OR Thousand Oaks, CA. Business Unit: Pre-filled Syringes and Lyo Kit Platforms Employment Type: Contract Duration: 18 months (with possible extensions) Rate : $45 - $51/hour W2 Posting Date: 09/13/2023 Notes: Only qualified candidates need apply. Onsite, with some WFH flexibility. 3 Key Consulting is recruiting an Senior Engineer, Combination Devices for a consulting engagement with our direct client, a leading global biotechnology company. Job Description: Ideal candidate: Minimum of 1 YOE project managing experience. 5-10 YOE in Engineering with background in med device, biotech, (Aero and Auto would also be considered). Bachelors or Masters Preferred. Preferred systems experience: Solid works, CAD, Smartsheet' Lead and support the Prefilled syringe combination product platform team in both development and commercial lifecycle of prefilled syringe (PFS) configurations. Experience leading and managing project timelines and initiatives while reporting out to management. Scope includes a the full range of PFS devices and variants, such as; needle protection systems and different delivery volumes. The qualified candidate will lead technical teams to ensure successful device development of these mechanical devices. The Senior Engineer will work closely with team members acting as a project manager to develop detailed timelines for ensuring engineering specifications, device design & development, verification, validation, and regulatory submissions of these devices are completed on time. Top Must Have Skill Sets: Project Management Technical understanding of design controls Device Engineering experience Day to Day Responsibilities: Supporting platform and product development teams by acting as a project manager to ensure timelines and delivery dates are met. Providing technical support and insights to team members and leading platform initiative projects. - Create and execute to project plans and schedules; responsible for ensuring team meets project timelines - 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. - Support development, execution, and review of 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. Basic Qualifications: - BS in Engineering and previous experience in a medical device industry - 5-10 years current experience with engineering processes and procedures. -Project Management experience - Strong background in engineering and commercialization of 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 - Experience in drug/device combination product design and development - Strong problem solving, risk assessment, and risk management skills - Must be capable of working on multiple projects in a deadline driven environment. Preferred Qualifications: Why is the Position Open? Supplement additional workload on team Red Flags: No Job hopping Interview Process: Initial Phone screenings and then Webex interviews with a panel of 3-6 team members. Series of 1:1 interviews We invite qualified candidates to send your resume to resumes@3keyconsulting.com. If you decide that you’re not interested in pursuing this particular position, please feel free to take a look at the other positions on our website www.3keyconsulting.com/careers. You are also welcome to share this opportunity with anyone you think might be interested in applying for this role. Regards, 3KC Talent Acquisition Team