Manufacturing Engineer, Design Transfer

Administrative Services            ·              Salt Lake City, UT                ·             Full time / Part time

Manufacturing Engineer, Design Transfer

• Administrative Services
• Salt Lake City, UT

Our Mission

Blackrock Neurotech is 100% focused on improving human lives through neuroscience research and technology. The passion and dedication behind this mission has nurtured a dynamic, enjoyable and fulfilling corporate environment in which learning, and growth are commonplace. We operate in an innovative field that requires our staff to meet the highest standards. Every step of the way, we encourage one another by providing continuous motivation and promoting a healthy work environment.

Disclosure

In order to provide a safe and productive work environment, all offers of employment at Blackrock Neurotech are contingent upon a thorough background check. A criminal history will not automatically disqualify a candidate from an offer of employment

Location: Salt Lake City, UT

Position Overview:

Responsible for ensuring efficient transfer of products from R&D to production and providing engineering support to the Operations and Electronics Manufacturing teams.  

Qualification Requirements

• BS in Mechanical, Electrical, Manufacturing or Biomedical Engineering (or equivalent)
• Minimum three (3) years of experience in a manufacturing environment

Ideal Competencies

• Knowledgeable in Design Control Processes
• Knowledgeable in lean manufacturing principles
• Knowledgeable in cGMP
• Electromechanical assembly experience
• Familiar with ERP systems
• Familiarity with medical device requirements

Essential Job Duties

• Providing input to R&D during the Design Control Process regarding requirements for smooth transition of product into production.
• Evaluating the manufacturability of products prior to design transfer.  This includes identifying shortcomings that could put the project at risk.
• Providing fully costed BOMs and updated COGs estimates prior to design transfer.
• Verifying that all vendors are on the Approved Supplier List and resolving any gaps.  Responsible for ensuring non-disclosure agreements are in place where required and that vendors have been appropriately added to the ERP system.
• Verifying status of components transferred to production to minimize delays related to long lead time, EOL or obsolete components and identifying alternate components where appropriate.
• Creation of part specification documents with input from the design engineer and ensuring parts are correctly set up within the ERP system.
• Creation and maintenance of Device Master Records (DMRs)
• Initiating and coordinating pilot runs.  This includes providing product training to Manufacturing Technicians and Engineers
• Ensuring that Manufacturing is equipped with all the test equipment/fixtures, software, programming tools, jigs and assembly tools/materials required for assembly prior to pilot runs.
• Periodic review/update of released BOMs to identify and address supply chain issues. 
• Preparation of product for sterilization, communication with the sterilizer, and coordination of documentation updates with the sterilization facility.  
• Providing support as needed to the Operations and Electronics Manufacturing teams (e.g. troubleshooting, deviations, resolution of non-conformances)

Physical and other requirements

• Ability to work in an office setting
• Sitting and standing while typing
• Ability to lift-up to fifty pounds
• Strong organization skills and attention to detail
• Excellent oral, listening and written communication skills
• Excellent problem-solving skills
• Excellent at taking initiative
• Ability to work independently with little supervision
• Ability to handle stressful situations
• Must be proficient in computer skills and the use of Microsoft Office

Please click here to apply.