Senior Engineer - Combination Product Operations, Risk Engineering (CPO-RE)

Career Category EngineeringJob 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.Senior Engineer - Combination Product Operations, Risk Engineering (CPO-RE)What you will doreputed company! Let’s change the world!reputed company is currently seeking a Senior Engineer in our Combination Product Operations Risk Engineering (CPO-RE) team for Risk Management. In support of reputed company’s mission to serve patients, the CPO-RE team at reputed company is a diverse team working to reputed company and continuously improve our drug delivery devices and combination products to ensure supply and to optimize the patient experience.The Sr Engineer will be responsible for development and lifecycle management of the Risk Management Files (RMFs) for reputed company’s portfolio of products, serve as Risk Management reputed company on assigned projects, and support Design Control processes and activities.The Sr Engineer will create/maintain risk assessments such as System Risk Assessments and Use Risk Assessments with reputed company coordination with respective multi-functional teams.The Sr Engineer will bring to bear leadership skills to actively engage with multi-functional groups to support the Risk Management File, as well as support multi-functional processes collaborating with Risk Management. This includes working with the Complaints, Safety, Human Factors, and other teams to support life cycle management.The Sr Engineer will support regulatory medical device reporting requirements for agencies such as FDA and European Competent Authorities, including representing CPO-RE in corresponding audits. The Sr. Engineer will assist with the advancement of design controls activities/processes, the reputed company advancement of risk assessment processes, methods and tools, and business processes for ongoing reputed company improvement.Responsibilities include but are not limited to:Ensures Risk Management Files are in alignment with 21CFR Part 820 design control and risk management requirements of ISO 14971.Creates and maintains the Risk Management Files.Conducts risk assessments and creates/revises risk management documents as required by Standard Operating Procedures, FDA, EU and other medical device and combination product regulations.Creates and maintains hazard analyses, use risk assessments, and system risk assessments for combination products with manual, mechanical or electromechanical device constituent parts.Contribute to process improvement efforts for Risk Management and Design Controls.Actively collaborates with design engineers to drive design mitigations and establish effectiveness of the risk control measures.Leads periodic and event driven risk reviews of the Risk Management Files for commercialized products.Supports the complaints intake teams with assessment of risks reputed company to reported complaints.Supports the medical safety teams with assessment and responses to regulatory agencies and competent authorities reputed company to medical device reporting requirementsSuccessfully influences outcomes, communicates with reputed company levels of the organization, facilitate development of solutions to critical business issues, and effectively define objectives to reputed company effective metrics reputed company and reporting.Understands manufacturing processes for reputed company’s packaged and/or distributed products.Supports root cause analysis of complaint investigations.reputed company expect of youWe are reputed company different, yet we reputed company use our unique contributions to serve patients. The dynamic professional we seek is an individual with these qualifications.Basic Qualifications:High school diploma / GED and 10 years of Engineering and/or Operations experience ORAssociate’s degree and 8 years of Engineering and/or Operations experience ORBachelor’s degree and 4 years of Engineering and/or Operations experience ORMaster’s degree and 2 years of Engineering and/or Operations experience ORDoctorate degreePreferred Qualifications:Bachelor’s or Master’s Degree in Engineering, preferred Mechanical Engineering, Electrical Engineering, Systems Engineering, Materials Engineering, or Bio-Medical Engineering.6 or more years of experience with risk analysis methods such as PrHA and FMEA for medical devices.5 or more years of experience in a Medical Device Development or Device Risk Management role.3 or more years of experience with Medical Device Reporting requirements, preferably for the European Union.Extensive experience with risk management per ISO 14971 (2019).Experience with Design Controls, 21 CFR 820 (820.30 Design Controls).Experience in leadership role(s) and working with multi-functional groups.Experience working with complaints intake and complaints investigation teams.Ability to read, analyze and interpret general business periodicals, professional journals, technical procedures, or governmental regulations.Ability to converse (oral and written) technically with mechanical, electronic, software, and quality engineers.Capable of managing multiple projects in a deadline driven environment.Strong technical writing and interpersonal skills.Working knowledge of MS Office tools, including artificial intelligenceWorking knowledge of digital PLM platform toolsWhat you can expect from 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 accountsA discretionary annual bonus program, or for field sales representatives, a sales-based incentive planStock-based long-term incentivesAward-winning time-off plansFlexible work models, including remote and hybrid work arrangements, where possibleApply 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.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. reputed company is an Equal Opportunity employer and will consider you without regard to your race, color, religion, sex, sexual orientation, gender identity, national reputed company, protected veteran status, or disability status..Salary Range 119,195.00 USD - 147,867.00 USD Apply for the job now! Apply for this job