Engineer (Product Development/DHF)

Position Title: Engineer (Product Development/DHF)

Location: North Chicago, IL, US 60064

Contract Period: 12 Months

Shift Timings: Mon - Fri, 08:00 AM - 05:00 PM CST.

MUST HAVE 5 YEARS OF MEDICAL DEVICE INDUSTRY EXP.

Hybrid Role

Schedule: Eight hours a day, forty hours a week. There will be occasional overtime required based on the need and urgency of project deliverables.

On Site: Hybrid onsite schedule is possible. Based on the need of the work there might be weeks where onsite is needed for the full week. There might be one day in two weeks that the candidate may be able to work from home to complete documentation based on project deliverable.

LOCAL Candidates would be considered as 1st preference

Manager's Update:

• Minimum educational qualification: BS Degree
• This role is falls under Product Development Science & Technology (PDS&T) team/dept.
• Must have prior medical device industry exp. is required
• Able to work with on market devices
• Combination Product Medical Device focused
• Focusing on Class I-III medical devices
• Must have exp. with DHF
• Must have prior change control/Management exp.
• Master's degree would be considerable
• Must have prior testing exp. is required
• Supplier change, FDA and EU regulation exp. is required in this role
• Computer skills are required

Must have Skills:

• DHF
• Change Management/Control
• Medical Devices

What are the top 3-5 skills, experience or education required for this position:

• 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

Reason:

• 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.

Skills:

• 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. In addition to product support, you will also be responsible for standardizing and simplifying activities within the team to enable more efficient development and marketed product support.

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.

Environment:

• Medical device/pharmaceutical development, office and laboratory settings.