Medical Device Senior Supplier Quality Engineer; R&D Engineer, R&D Process Development Engineer

I'm a medical device recruiter specializing in the placement of R&D, Quality, and Manufacturing engineers and managers. My clients vary in size from development-stage, to very large, minimally invasive cardio/peripheral vascular medical device companies. My clients are located primarily in the Western United States.  Here are the details of a few of the positions I'm working on in the Bay Area:

 

Sr. Supplier Quality Engineer (2 positions) up to $100k:

Represents the Quality Engineering Department in relation to Acclarent’s suppliers. Communicates and provides feed-back to suppliers regarding performance and compliance to specifications. Coordinates Material Review Board activities for Incoming Inspection. Performs supplier audits. Addresses quality issues related to suppliers, participates in root cause identification and coordinates Supplier Corrective Actions.

Supervises and provides technical guidance for Receiving Inspection. Monitors, analyzes and reports supplier performance and QA Testing data in Management Reviews.

 

Provides back-up support to Production Quality Engineers. Leads and participates in continuous improvement projects. Audits compliance to QSR, ISO13485:2003, suggests corrective actions and tracks their implementation.

 

Requirements:

 

Bachelor's degree in Engineering plus minimum of 5 years experience in a medical device manufacturing environment. Requires strong problem solving and statistical skills and thorough knowledge of medical device GMPs and ISO standards applicable to the FDA and international regulatory agencies. Superior time management and excellent communication skills required. Supervision experience required. Available to travel ~ 20% of the time. Familiarity with SPC and ANSI sampling plans preferred.

R&D Engineer; up to $115k Menlo Park

Responsibilities:Support nitinol stent design activitiesSupport catheter development activitiesCoordinate external testing resourcesDesign and maintain test equipmentCoordinate verification and validation activitiesConductProtocols (stent and system)Test data analysis, including statistical analysisReport generationAdhere to timeline for project, identify resource constraints and requirementsContinuously evaluate timeliness of activities and regularly communicate statusCoordinate resources within other departments as necessaryMaintain laboratory notebookPerform design and failure analysis, reliability studiesParticipate in competitor analysis

Job Requirements

Must:Hard worker and self-starterSense of urgency and passionAn ability to get things doneStent or delivery system experienceDegree in Mechanical or Electrical Engineering or equivalent

 Preferred:Stent/delivery system design experience, fatigue testingExperience working with nitinolStrong organizational skillsAutoCAD or SolidWorks skills3 to 5 years successful product development experience in medical device environment

 

R&D Process Development Engineer; Mtn. View up to $115k

This process engineering position involves developing, refining and validating new and existing manufacturing processes. This includes the creation of manufacturing processing documentation and equipment operating instructions and the design, construction, and validation of assembly fixtures, machines and tooling for manufacturing and test equipment. The role will involve identifying opportunities to improve process controls, reduce takt time and increase manufacturing throughput.

The candidate will be expected to qualify and execute quality improvement lean initiatives on the current manufacturing line as well as participate in new product project teams, providing design for manufacturing input during the product design phase and help complete Make/Buy decisions on components and sub-assemblies. The position involves working to aggressive timescales, so this role is best suited to a professional who is able to deliver exceptional results in a pressured environment. This is a great opportunity for someone who takes pride in their work and is looking for career development.

 

 

Position Responsibilities:Design, development and validation of new manufacturing lines.Participates in new product project team activity, supporting design for manufacturing elements. Designs, constructs and validates assembly, manufacturing, and test equipment/fixturing supporting a Lean manufacturing environment. Documents new processes and help train operators.Generates, collects and analyzes test data and writes technical reports and prepares specifications, and orders materials and components.  Identifies, qualifies, and executes quality improvement/cost savings initiatives on current manufacturing lines.Works with outside suppliers to develop semi-automated manufacturing processes where appropriate.Helps transfer production lines to outside manufacturers as requiredLimited travel will be required. Performs other duties as assigned.

 Basic Qualifications:Bachelors Degree in an engineering discipline5+ years experience in medical device industry.  Hands on experience with setting up production lines for disposable medical devicesTrained in Six Sigma practices, statistical data analysis and lean manufacturing preferred