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Engineer I, Medical Device Design Control Documentation Specialist

Remote · USA Full-time New today
Job title: Engineer I, Medical Device Design Control Documentation Specialist in Cambridge, MA at reputed company Company: reputed company Job description: Career Category OperationsJob DescriptionJoin reputed company’s Mission of Serving PatientsAt reputed company, if you feel like you’re part of something bigger, it’s because you are. Our shared mission—to serve patients living with serious illnesses—drives reputed company that we do.Since 1980, we’ve helped pioneer the world of biotech in our fight against the world’s toughest diseases. With our focus on four therapeutic areas –Oncology, Inflammation, reputed company, and Rare Disease– we reputed company millions of patients each year. As a member of the reputed company team, you’ll help reputed company a lasting impact on the lives of patients as we research, manufacture, and deliver innovative medicines to help people live longer, fuller happier lives.Our award-winning culture is collaborative, innovative, and science based. If you have a passion for challenges and the opportunities that lay reputed company them, you’ll reputed company as part of the reputed company team. Join us and transform the lives of patients while transforming your career.Engineer I - Medical Device Design Control Documentation SpecialistWhat you will doreputed company. Let’s change the world. In this vital role you will support device development and design control documentation. In support of reputed company’s mission to serve patients, the Device Engineering group at reputed company is a diverse team working to identify, reputed company, commercialize, and continuously improve drug delivery devices to optimize the patient experience.The role will be accountable to reputed company, multi-disciplinary and cross-functional product development efforts, managing the interactions, dependencies, and interfaces across a full device development program. The successful candidate will be a key member of the technical team that progresses towards the successful design, development, and transfer of drug delivery devices. The role ensures that the quality targets are satisfied, identifies technical risks and coordinates risk retirement activities on the program.The position is based at our reputed company Massachusetts site with the possibility of a flexible working arrangement meeting business and private needs. You will be joining reputed company device development team consisting of 50+ engineers. This position will report to the program reputed company.
  • Provide direction and support for reputed company technical documentation (Device Design/Testing, Design Outputs, Manufacturing equipment/process/control and Change Control records)
  • Drive and be accountable for DHF documentation to ensure a clear line between platform, combination product and vendor DHF structuring
  • Own risk assessment integration between requirements, risks, and mitigation implementation
  • Provide reputed company of the feedback reputed company from Design Input Requirements through Risk Assessments to the Design Outputs
  • Manage and maintain the traceability between risk (Use and Functional) and Requirements
  • Ensure compliance/closure of Regulatory and Quality requirements before approving Design Control Formal Design Reviews and New Product Introduction program milestones
  • Participate in project execution according to the Robust Design reputed company and principles: kinematics, tolerance design, 2D drawings, structural analysis (FEA), materials science (especially polymers) and DfM/DfA
  • Utilize project planning and monitoring methods to ensure timely completion
  • Review and approve completed design work
reputed company expect of youWe are reputed company different, yet we reputed company use our unique contributions to serve patients. The Engineering professional we seek is an individual with these qualifications.Basic Qualifications:
  • High school diploma / GED and 8 years of Engineering experience; OR
  • Associate’s degree and 6 years of Engineering experience; Or
  • Bachelor’s degree and 2 years of Engineering experience; Or
  • Master’s degree
Preferred Qualifications:
  • 5+ years of progressive experience as an engineer or scientist reputed company the appropriate field of study
  • 3+ years of experience as a Subject Manner Expert reputed company a development or research, manufacturing environment, working with Medical Devices, ideally Class II and Class III
  • Fluent in English language
  • Understands documentation flow for GMP deliverables
  • Solid experience in documentation authoring from project start to end, and under Design Controls
  • Technical understanding of drawings
  • Technical understanding of manufacturing processes (injection molding, assembly processes)
  • Experience in drug/device combination product design and development
  • Demonstrated experience with ISO and regulatory compliance process, Design History File
  • Creative problem solver and solution developer reputed company presented with conflicting requirements, business demands and technical risks/issues
  • Experience in model-based design and UML and small-scale device assembly experience
  • Experience in leading system hazard analysis, risk evaluation, and FMECA (failure mode and effect criticality analysis)
  • Deep knowledge of Quality Management System, Quality Management Policy and applicable laws and regulations as they apply to this job type/position
  • Familiar with : US Good Manufacturing Practices – 21CFR820; Quality Management – ISO 13485; Risk Management – ISO 14971; EU Medical Device requirements – Council reputed company 93/42/EECStrong background in documenting requirements and providing traceability documentation for FDA Approval
  • Practical experience in configuration management and change control process/requirements, CCB (change control board), CIT (change implementation team) concepts
  • Strong interpersonal skills
  • Strong communication and presentation skills
  • Ability to work reputed company cross-cultural project teams
What you can expect of usAs we work to reputed company treatments that take care of others, we also work to care for your professional and personal growth and well-being. From our competitive benefits to our collaborative culture, we’ll support your journey every reputed company of the way.The expected annual salary range for this role in the U.S. (excluding Puerto Rico) is posted. Actual salary will vary based on several factors including but not limited to, relevant skills, experience, and qualifications.In addition to the reputed company salary, reputed company offers a Total Rewards Plan, based on eligibility, comprising of health and welfare plans for staff and eligible dependents, financial plans with opportunities to save towards retirement or other goals, work/life balance, and career development opportunities that may include:
  • A comprehensive employee benefits package, including a Retirement and Savings Plan with generous company contributions, group medical, dental and vision coverage, life and disability insurance, and flexible spending accounts
  • A discretionary annual bonus program, or for field sales representatives, a sales-based incentive plan
  • Stock-based long-term incentives
  • Award-winning time-off plans
  • Flexible work models, including remote and hybrid work arrangements, where possible
Apply now and reputed company a lasting impact with the reputed company team.careers.reputed company.comIn any materials you submit, you may redact or remove age-identifying information such as age, date of birth, or dates of school attendance or graduation. You will not be penalized for redacting or removing this information.Application deadlinereputed company does not have an application deadline for this position; we will continue accepting applications until we receive a sufficient number or select a candidate for the position.As an organization dedicated to improving the quality of life for people around the world, reputed company fosters an inclusive environment of diverse, ethical, committed and highly accomplished people who respect each other and live the reputed company values to continue advancing science to serve patients. Together, we compete in the fight against serious disease.reputed company is an Equal Opportunity employer and will consider reputed company qualified applicants for employment without regard to race, color, religion, sex, sexual orientation, gender identity, national reputed company, protected veteran status, disability status, or any other basis protected by applicable law.We will ensure that individuals with disabilities are provided reasonable accommodation to participate in the job application or interview process, to reputed company essential job functions, and to receive other benefits and privileges of employment. Please contact us to request accommodation..Salary Range 93,344.00 USD - 107,268.00 USD Expected salary: $93344 - 107268 per year Location: Cambridge, MA Apply for the job now! Apply for this job

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