Report this job

---

What is the problem? *

Incorrect company
Incorrect location
Job is expired
Job may be a scam
Other

What is the top three to five technical skill requirements? Product life cycle management experience, medical device experience, design development and transfer experience,
What is the top three to five soft skill wants? Good verbal and written communication, hard worker, curious to learn new things, critical thinker
Is this position onsite or remote? Onsite (hybrid)
o If onsite in Deerfield will it follow a hybrid model and what does the look like on your team? Hybrid includes 3 days onsite, 2 remote.
What is the expected interview process? I expect to have WebEx interview with camera on with myself and other team members individually.

Responsible for supporting the development of new products and on-market products used in surgical procedures. This person should be able to work in a matrix environment through partnerships with R&D and other cross functional team members. This position is in need of a strong understanding of Quality compliance by building quality into products using design control and risk management principles in compliance with regulatory standards and client procedures.

Essential Duties and Responsibilities:
Applies state of the art techniques in the area of expertise to support the development of new or improved products
Supports the sustainability and life cycle management of existing products
Ensures compliance with global quality systems and Regulatory requirements related to product and process
Provides Quality Assurance support and guidance for verification and validation of product requirements
Performs design change control activities including impact assessments, reviews, and approvals
Takes lead role in CAPA activities such as investigation, implementation, or verification of effectiveness
Supports risk management activities as they relate to product and post market surveillance
Interacts with on-shore and off-shore suppliers to complete project related activities
Applies a solid understanding of theories/practices utilized by other disciplines outside the primary area of expertise toward the development of new or enhanced products
Plans, executes, and works with minimal supervision and independent judgment

Qualifications:
Must have experience working with all classes of Medical devices preferably implantables, Biologics, and/or combination products with advanced training and demonstrate proficiency in problem solving, total quality management, DHF remediation, Risk file remediation, EUMDR, problem analysis and resolution, and design of experiments
Experience with New product development activities as R&D lead or QE lead in various product development teams
Demonstrates leadership skills to handle sustaining product support activities involving Complaint investigations, Trigger evaluations and Change controls
Extensive cross-functional team experience, including technical and non-technical work
Strong interpersonal, communication, influencing, and negotiation skills

Education and Experience:
B.S. degree in Engineering with at least 1-3 years of experience working in a regulated environment
Higher degrees desired with relevant experience in medical device industry
Demonstrated success in delivering results on several technical challenges
Working knowledge of medical device international standards