Engineer (Product Development/DHF)
Wall Street Consulting Services LLC · North Chicago, Illinois, United States
FULL TIMEpermanent
Job Description
Position Title: Engineer (Product Development/DHF)Location: North Chicago, IL, US 60064Contract Period: 12 MonthsShift Timings: Mon - Fri, 08:00 AM - 05:00 PM CST.
Want to apply Read all the information about this position below, then hit the apply button.
MUST HAVE 5+ YEARS OF MEDICAL DEVICE INDUSTRY EXP.
Hybrid RoleSchedule: 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 preferenceManager's Update:
Minimum educational qualification: BS DegreeThis role is falls under Product Development Science & Technology (PDS&T) team/dept.Must have prior medical device industry exp. is requiredAble to work with on market devicesCombination Product Medical Device focusedFocusing on Class I-III medical devicesMust have exp. with DHFMust have prior change control/Management exp.Master's degree would be considerableMust have prior testing exp. is requiredSupplier change, FDA and EU regulation exp. is required in this roleComputer skills are requiredMust have Skills:DHFChange Management/ControlMedical DevicesWhat are the top 3-5 skills, experience or education required for this position:Design History File product lifecycle management experienceEngineering degree, bioengineering, chemical or mechanical engineering degreeOn-market supplier changesKnowledge 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 vendorsReason: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. xzbcwsv Environment:Medical device/pharmaceutical development, office and laboratory settings.
Want to apply Read all the information about this position below, then hit the apply button.
MUST HAVE 5+ YEARS OF MEDICAL DEVICE INDUSTRY EXP.
Hybrid RoleSchedule: 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 preferenceManager's Update:
Minimum educational qualification: BS DegreeThis role is falls under Product Development Science & Technology (PDS&T) team/dept.Must have prior medical device industry exp. is requiredAble to work with on market devicesCombination Product Medical Device focusedFocusing on Class I-III medical devicesMust have exp. with DHFMust have prior change control/Management exp.Master's degree would be considerableMust have prior testing exp. is requiredSupplier change, FDA and EU regulation exp. is required in this roleComputer skills are requiredMust have Skills:DHFChange Management/ControlMedical DevicesWhat are the top 3-5 skills, experience or education required for this position:Design History File product lifecycle management experienceEngineering degree, bioengineering, chemical or mechanical engineering degreeOn-market supplier changesKnowledge 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 vendorsReason: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. xzbcwsv Environment:Medical device/pharmaceutical development, office and laboratory settings.
Details
| Company | Wall Street Consulting Services LLC |
| Location | North Chicago, Illinois, United States |
| Type | FULL TIME |
| Niche | tech |
| Experience | permanent |