Essential Duties and Responsibilities

• Lead the creation and maintenance of customer specific design history files (DHF) including product requirements, design inputs, trace matrix, design outputs, design verification, and risk management.
• Ensure on-market products maintain compliance with industry standards, West QMS and agreed to customer requirements.
• Lead product change control requests including conducting impact assessments, updating DHF documentation, conducting engineering and/or verification testing and review of risk documents.
• Act as the primary point of contact for product specific inquiries and requests from customers
• Facilitate assessment and implementation of customer (internal and external) product requests. Serves as the interface between the customer’s technical team and West’s technical team for on-market products.
• Accountable for identifying, investigating and analyzing problems with product design and recommend solutions.
• Prepare reports and presentations for internal, external, and cross-functional teams.
• Conforms with and abides by all regulations, policies, work procedures, instruction, and all safety rules.
• Exhibits regular, reliable, punctual and predictable attendance.
• Performs other duties as assigned based on business needs.

Additional Responsibilities

Education

• Bachelor's Degree Mechanical, Biomedical or related Engineering field required

Work Experience

• Minimum 3 years Related work experience required

Preferred Knowledge, Skills and Abilities

• Background in medical device development or on-market sustainment
• Knowledge of FDA medical device design controls (21 CFR 820.30)
• Excellent communication skills including interactions with customers
• Knowledge of statistics and Minitab
• Project management skills
• Able to be aware of all relevant SOPs as per Company policy as they are related to the position covered by this Job Description
• Able to comply with the company’s safety and quality policies at all times

License and Certifications

Travel Requirements

Physical Requirements

Additional Requirements

What We Offer

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