Overview

The Manufacturing Engineer II works closely with Operations, Sustaining Engineering and Quality to identify and quickly resolve any issues with the design or process of the NanoString or OEM production lines. This individual is part of the driving force to maintain quality and effectively resolve any production issues. Key to the role is the timely and appropriate response to urgent matters, the ability to apply sound judgment to problem resolution, management of the engineering change pipeline, and the escalation of issues to the management level and others in the organization when appropriate.

Responsibilities

Essential Functions:

• Manage the processes around the instrument manufacturing.
• Maintain and update the WI and production documents such as DHR, certifications and logs.
• Responsible for ensuring execution of WI, calibration, test, ongoing quality improvements, and change control activities
• Participate in the optimization of processes, material and manufacturing strategies
• Implement standardization and consistency across all company production lines.
• Participate in evaluating new suppliers and contract manufacturers. Lead strategies for continuous cost and quality improvement programs
• Proactively support Operations in company growth and improvement efforts. Lead and implement first article inspections and quality tests

Qualifications

• Qualifications and Requirements (Education, Experience, Specific Skills):

  • S and or M.S. in Electrical Engineering or Mechanical Engineering
  • 3-5 years of experience working for a fast paced manufacturing environment, ideally in the medical device industry with strong understanding of FDA regulations and experience working under FDA guidelines
  • Proven track record of working with SolidWorks CAD software and Enterprise Product Data Management (EPDM) systems
  • Experience working within an ERP system.
  • Knowledge of instrumentation and accessories.
  • Experience with manufacturing tools such as Statistical Process Control methods and Lean principals.
  • Familiarity with these engineering principles:

• Familiarity with these engineering principles:
• injection molding
• Sheet metal
• Casting
• Machined
• Purchased fluidics components
• Purchased optical comonents
• Motion control
• Optical (excitation and fluorescence)
• Knowledge of quality control principles, business processes, management systems and common software applications
• Analytical and creative problem solving skills
• Excellent communication skills, ability to clarify issues and reach consensus with an audience
• Ability to listen and understand customers’ and others’ issues and concerns, both technical and operational
• Ability to set goals for the team and achieve scheduled deadlines
• Ability to work independently and collaboratively
• Ability to work in an entrepreneurial environment with limited resources; ability to multi-task and take a creative approach to problem solving
• Experience working within an ISO 9001 or ISO 13485 quality system
• Proficient in the use of MS Office
• Demonstrated problem solving skills in a complex environment and in complex situations

Desired:

• Familiarity with these engineering principles:
• Mechanical/mechanism design
• Fabrication methods (injection molding, machining, etc.)
• Fluidics/microfluidics
• Optics (excitation and fluorescence)
• Electrical components, PCB, hardware
• Measurement and inspection
• GD&T and tolerance analysis
• Knowledge of project management techniques
• Experience working within an ISO 9001 or ISO 13485 quality system

At Bruker, base salary is part of our total compensation. The estimated base salary range for this full-time position is between $74,000 and $118,000 provides an opportunity to progress as you grow and develop within a role.The base salary for the role will depend on a several job-related factors, including, but not limited to education, training, experience, the geographic location of the successful candidate, skills, competencies, job-related knowledge and travel requirements for this position. Full-time employees may also be eligible for a performance-related incentive in addition to a full range of benefits including 401(k) with company match, an employee stock purchase plan, medical and dental plans, life insurance, short-term and long-term disability insurance, employee assistance program and paid time off including vacation, sick time and holidays, and more.

Bruker is an equal-opportunity employer. We evaluate qualified applicants without regard to race, color, religion, sex, sexual orientation, gender identity, national origin, disability, veteran status, and other legally protected characteristics.

Certain positions at Bruker require compliance with export control laws and as a result, all interviewed candidates for all positions will be screened pre-interview to determine their eligibility in light of export control restrictions.