Product Engineer,R&D

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.