Design Engineer

Responsibilities

• Lead product development efforts (project specific) through all phases of design (e.g. feasibility through transfer to manufacturing).
• Create and manage solid models, assemblies and drawings using SolidWorks and SolidWorks Vault.
• Manage and report on project timeline/completion of tasks to ensure timely completion as projected.
• Establish and implement validation requirements for products, test methods and manufacturing processes
• Write design and process validation protocols and reports.
• Write Hazard/Risk Analysis (per ISO14971) and FMEAs (Design and Use)
• Create Item Masters and Bills of Materials. Support their entry into ERP system
• Lead project document control efforts in the entering of documents into Quality System Vault and maintaining solid models not resident in the QS Vault (e.g. SolidWorks Vault).
• Create and maintain FDA compliant Design History Files (DHF).
• Support quality system compliance with FDA QSR and ISO 13485, and regulatory submissions.
• Develop, commercialize, and support innovative medical laser products
• Provide expertise and guidance on industry best practices and regulatory requirements

Qualifications

• BS in mechanical or relevant engineering discipline – biomedical engineering a big plus
• Strong background in medical device engineering
• 4 years of engineering experience in design and development of complex, medical electrical devices
• Working knowledge of quality systems regulations i.e., FDA QSR, ISO 13485, is required
• High degree of initiative and self-motivation with a strong sense of accountability

Job Disclaimer:

Equal Opportunity Employer/Veterans/Disabled

Benefit offerings include medical, dental, vision, term life insurance, short-term disability insurance, additional voluntary benefits, commuter benefits and 401K plan. Our program provides employees the flexibility to choose the type of coverage that meets their individual needs. Available paid leave may include Paid Sick Leave, where required by law; any other paid leave required by Federal, State or local law; and Holiday pay upon meeting eligibility criteria. Disclaimer: These benefit offerings do not apply to client-recruited jobs and jobs which are direct hire to a client

To read our Candidate Privacy Information Statement, which explains how we will use your information, please visit https://www.entegee.com/candidate-privacy-information-statement/

The Company will consider qualified applicants with arrest and conviction records.

Job Types: Full-time, Permanent

Pay: $130,000.00 - $170,000.00 per year

Benefits:

• 401(k)
• 401(k) matching
• Dental insurance
• Health insurance
• Life insurance
• Paid time off
• Vision insurance

Experience level:

• 4 years

Schedule:

• 8 hour shift
• Day shift

Education:

• Bachelor's (Required)

Experience:

• Medical Device Engineering: 4 years (Required)
• Design and development: 4 years (Required)
• Solidworks: 4 years (Required)

Work Location: In person