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Job Description
Job Summary
The Assoc, Product Engineer will be responsible for executing development and sustainment activities of handheld and wearable drug delivery systems This role has frequent interactions with West's medical device customers and requires close collaboration with Platform Development, Quality, Regulatory Affairs, Manufacturing, Account Management.
The individual will leverage their excellent problem-solving acumen, analytical, project management, solving customer service and engineering abilities to effectively drive the development and maintenance of West medical devices.
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
10%: Up to 26 business days per year
Physical Requirements
Sedentary-Exerting up to 10lbs/4kgs of force occasionally, and/or negligible amount of force frequently or constantly to lift, carry, push, pull, or otherwise move objects, including the human body. Sedentary work involves sitting most of the time.