Engineer

Duties :

• The Combination and Medical Device Products Consumable Device US team is expanding their support for on-market devices.
• This role will be responsible for on-market change execution, product life cycle management, and manufacturing support specific to the product design.
• Responsible for standardizing and simplifying activities within the team to enable more efficient development and marketed product support.
• Environment: Medical device/pharmaceutical development, office and laboratory settings.

Requirements :

• Bachelor of Science degree with 3+ years of experience, in medical device or pharmaceutical development roles.
• Desired: Graduate degree in a technical or scientific field.
• Prior experience of consumable medical device/pharmaceutical development.
• Design History File product lifecycle management experience
• Engineering degree, bioengineering, chemical or mechanical engineering degree
• On-market supplier changes
• Knowledge with applicable global regulatory requirements and industry standards (MDR requirements, ISO 13485, ISO 14971, ISO 10993, etc.)
• Exceptional written and verbal communication skills, and the ability to clearly articulate development challenges and implementation strategies to stakeholders across a broad range of functional groups at all layers of the organization including external vendors
• Proficiency with medical device/pharmaceutical DHF traceability required.
• Proficiency with test execution, deviation of reporting and management, data review, and report writing is required.
• Experience with medical device EU and/or FDA.

Benefits:

Healthcare Insurance: Synectics offers eligible employees and their dependents healthcare coverage through BlueCross BlueShield of Illinois. Eligibility begins on the 1st day of the calendar month following 60 days of continuous full time employment with Synectics. Premiums are subsidized by Synectics.

Dental Insurance: Synectics offers eligible employees and their dependents a dental plan through MetLife. Eligibility begins on the 1st day of the calendar month following 60 days of continuous full time employment with Synectics.

Vision Insurance: Synectics offers eligible employees vision insurance through VSP. Eligibility begins on the 1st day of the calendar month following 60 days of continuous full time employment with Synectics.

401(k) Plan: The Synectics Inc. Investment Savings Retirement Plan. Synectics offers all employees who are 21 years of age or older the opportunity to invest in the 401(k) Plan on the first of the month following at least 1 calendar year after employment begins.

Synectics is an equal opportunity employer.