Sr. Process Development Engineer



Advert ID




Job Type




Salary Range

Based on Experience

No. of Openings


Branch Information

Minnesota Engineering - (USA) 3600 Minnesota Drive Suite 850 MN Edina , MN 55435



Job Description

A medical device client of ours is seeking a Senior Process Development Engineer to be responsible for supporting new and existing products within interventional urology. This position will be the process development technical representative of their respective project teams. Training other process development staff, as well as mentoring other engineers on the team will be a part of this role. Candidates with active implantable experience are highly sought after, however client will consider experience in other medical device disciplines as well. This is a direct hire role located in Minneapolis, MN.

Major Areas of Accountability:

* Responsible for the following project inputs:

* Feasibility builds, documentation, and testing,

* Equipment selection,

* Process development and documentation,

* Device Verification samples and testing,

* Operator training,

* Process Failure Mode Effects Analysis,

* Clinical builds,

* Process Validation

* Involvement in the design, development, and validation requirements of projects, including:

* Product design and specification creation, including mechanical and electrical components, assemblies, and packaging,

* Materials sourcing and device prototyping,

* Manufacturing transfer and support of existing product lines as applicable.

Basic Qualifications:

* BS in Engineering (Mechanical preferred)

* 5+ years experience in medical devices (active implantable), not all required to be in process development

* Solid understanding of engineering concepts and principles

* Able to develop validation protocols and synthesize data to write test reports based on observed data, relevant test standards and general engineering knowledge

* Familiarity with statistical analyses; DOE and Gage R&R execution

* Familiarity with FDA, ISO and EN Standards as they apply to medical devices

* Good understanding of Quality Management Systems and standard operating procedures

* Ability to travel up to 10%