Design Engineer II
150 Dan Road, Canton, Massachusetts, 02021, United States
Job Req code 596
Category : Engineering
What You Will Achieve :
Use diverse engineering skills to design, approve, and test new product designs. Projects will focus on, but will not be limited to, conducting reliability assessments, evaluating existing products, and monitoring design developments to maintain quality compliance and assist in engineering, testing, and validation.
How You Will Achieve It :
- Supports new product development and establish quality and reliability of the finished product.
- Participates in projects to improve product yield increase capacity and / or reduce overall production cost.
- Write and conduct test protocols, test reports, validation protocols and reports.
- Supports various aspects of design, prototyping, fabrication and testing with consideration given towards end product requirements (patient safety and efficacy).
Requirements
What You Need to Achieve It :
Bachelor’s Degree in Mechanical Engineering2 to 5 years’ experience in a medical device / pharmaceutical’s environmentAbility to work on multiple projects simultaneously.Working experience with MS OfficeAbility to read, write functional requirement specifications, follow verbal instructions, interpret technical procedures, and technical writing skillsAbility to solve practical problems both individually and in a team environmentAbility to communicate effectively with other employees.Familiar with validation methods (IQ / OQ / PQ) is highly desirable.Excellent problem solving and time management skills.Excellent attention to detail Knowledge of ISO 9001 : 2000, ISO 13485, U.S. F.D.A., Q.S.R. and working knowledge of appropriate industry standards.Write and conduct test protocols, test reports, validation protocols and reports.Experience in application of statistical methods to design reliability and process capability.Experience with Instron or bubble emission equipmentExperience in medical device design and application of test standardsAbility to work in a fast-paced environmentBasic understanding plastic materials including thermoforming and injection molding.Basic design understanding of machining, molding, tolerances, finishes, fits and GD&TWhat can we offer you?
401k generous employer match with immediate vesting and financial planning resourcesComprehensive Medical, Dental and Vision coverage options effective on day one of employmentFlexible Spending Account (medical expenses or dependent care expenses) or Health Savings AccountCompany paid insurances including Short Term, Long Term and Life insurances as well as voluntary optionsPaid maternity leave and parental leave for all new parentsAdoption benefitsEducation Assistance Policy - $5,000 per year for all employeesWellness Program including free trainings on mental health, mindfulness, stress reduction, on-site flu shots and moreEmployee Assistance ProgramGenerous paid time off including vacation, floating holidays, sick days, and company holidaysFree parking including an electric charging station (Canton and La Jolla)Discounts at BJs Wholesale, Dell, Sullivan Tire, and SprintWe are an equal opportunity / affirmative action employer. All qualified applicants will receive consideration for employment without regard to age, sex, gender identity, sexual orientation, race, color, religion, national origin, disability, protected veteran status, genetic information or any other characteristic protected by law.
We do not accept unsolicited agency resumes and we are not responsible for any fees related to unsolicited resumes.