Design Engineer II

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).

Job Requirements

What You Need to Achieve It:

• Bachelor's Degree in Mechanical Engineering
• 2 to 5 years' experience in a medical device/pharmaceutical's environment
• Ability to work on multiple projects simultaneously.
• Working experience with MS Office
• Ability to read, write functional requirement specifications, follow verbal instructions, interpret technical procedures, and technical writing skills
• Ability to solve practical problems both individually and in a team environment
• Ability 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 equipment
• Experience in medical device design and application of test standards
• Ability to work in a fast-paced environment
• Basic understanding plastic materials including thermoforming and injection molding.
• Basic design understanding of machining, molding, tolerances, finishes, fits and GD&T

What can we offer you?

• 401k -- generous employer match with immediate vesting and financial planning resources
• Comprehensive Medical, Dental and Vision coverage options effective on day one of employment
• Flexible Spending Account (medical expenses or dependent care expenses) or Health Savings Account
• Company paid insurances including Short Term, Long Term and Life insurances as well as voluntary options
• Paid maternity leave and parental leave for all new parents
• Adoption benefits
• Education Assistance Policy - $5,000 per year for all employees
• Wellness Program including free trainings on mental health, mindfulness, stress reduction, on-site flu shots and more
• Employee Assistance Program
• Generous paid time off including vacation, floating holidays, sick days, and company holidays
• Free parking including an electric charging station (Canton and La Jolla)
• Discounts at BJs Wholesale, Dell, Sullivan Tire, and Sprint

We 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.

Physical Required

Job Type

Full-time

Location

Organogenesis Inc. Headquarters Shipping Address/Apligraf Manufacturing - Canton, MA 02021 US (Primary)

Education

Bachelor's Degree

Career Level

Individual Contributor

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