We are looking for a Sr R&D Mechanical Engineer to work with our expert Cell and Gene Therapy – Disposables R&D team, based in Marlborough – USA, developing plastic disposable kits for working along with medical devices and manufacturing equipment aiming to process biological cells in the field of blood transplantation and cellular therapies. Do you have a passion for cell therapy? Then we would love to hear from you
We at Ian Martin envision a world where everyone is connected in meaningful work and if you find great meaning in developing some of the most widely used products in the world, then we have the career path for you.
What you’ll do
• Engage in all phases of new product design and/or legacy product re-design, development, including concept, architecture, documentation, design, prototype verification & validation, supplier interfaces, manufacturing introduction and service support.
• Elaborate with project team to develop product specifications and requirements to drive the product development process. Work from product specifications and requirements to develop component and assembly geometry, specify materials, and establish acceptable performance standards. Performs complex calculations, analyses, and testing to verify assumptions.
• Prepare engineering change requests, engineering change notices, bills of material, engineering specifications, and customer submittals. Revise and alter detailed and layout drawings to conform to engineering changes.
• Direct the construction and testing of prototype disposables and pilot products and conduct analysis of the test results.
• Prepare using 2D and 3D CAD software mechanical drawings, assembly models.
• Follow up of strategic suppliers providing plastic components such as injection molding, extrusions components or bags and supervise IQ, OQ, PQ, process FMEA supplier activities.
• Work in a multidisciplinary Research and Development team, in close interaction with the Production, Supply Chain, Sourcing, Quality and Sales & Marketing departments, as well as end-users and suppliers
Who you are:
• University degree or equivalent in related scientific or engineering fields (mechanics, plastics, material sciences, biomedical engineering, or micromechanics)
• 8 - 10 minimum years of successful experience in product launch, design R&D and project management, developing and manufacturing plastic disposable kit for the medical or life science industry (experience with Class II or Class III products)
• Well-founded knowledge and practical experience of relevant regulations (ISO13485, QSR 21CFR820, cGMP), specifically for the US and European market
• 8 - 10 minimum relevant years of experience with CAD Design (Advanced skills in SolidWorks).
• Excellent time management skills with ability to manage multiple priorities and deliver on time.
• Solid influence and interpersonal skills including ability to effectively formulate and convey technical and cost/benefit/risk information with peers and senior leaders.
• Able to influence course of action for own job area & modify own methods to achieve results in line with overall business needs and objectives.
• Able to work independently and exercise appropriate latitude when addressing abstract, yet to be defined technical issues and problems.
• Results focused. Able to deliver consistent, high quality work to meet product performance, compliance, schedule, and budget requirements.
• Able to provide solutions to a variety of technical problems of challenging scope and complexity.
• Able to work well under pressure and maintain positive, engaged attitude.
• Ability to demonstrate clear, factual, effective, oral and written communication with variety of cross functional colleagues, technical peers, and senior level management.
• Proficient in liaison, collaborator, and informal leadership roles. Able to facilitate cross functional group problem solving and decision making.
• Able to work independently, follow established procedures, give/receive technical peer reviews of work deliverables for accuracy of technical content and conclusions.
• Experience in single or multi uses disposables kit in medical device industry is a plus.
• Knowledge of plastic biocompatibility, leachable & extractable and sterilization techniques is a plus.
Looking for Meaningful Work? We can help.
If you are a R&D Mechanical Engineer, you know that it can be difficult to find fulfilling work that advances your career. At the Ian Martin Group, we exist to connect professionals like you with meaningful work at industry-leading companies in your field. And we walk the walk, too: as a Certified B Corporation, we believe in using business as a force for good for people, our communities, and the environment.
We value diversity and inclusion and encourage all qualified people to apply. If we can make this easier through accommodation in the recruitment process, please contact us at email@example.com.
We encourage all qualified candidates to apply; however, only those selected for an interview will be contacted.