Lead Product Support Engineer

2 weeks ago


Middleton, Wisconsin, United States Innova Solutions Full time

Job Overview:
In this role, you will be a pivotal member of the engineering team, focusing on sustaining engineering for manufactured products.

Key Responsibilities:

As a Lead Product Support Engineer, your primary responsibilities will include:

  • Providing advanced technical support for all design-related inquiries concerning released products and components.
  • Leading root cause analysis initiatives to identify and resolve engineering challenges.
  • Implementing modifications and enhancements to both products and manufacturing processes.
  • Utilizing problem-solving methodologies such as DMAIC, FMEA, and 5-Whys to address corrective and preventative actions.
  • Monitoring product issues and driving effective resolutions while tracking relevant metrics.
  • Supporting the development and maintenance of processes used in manufacturing and service activities.
  • Proactively addressing production interruptions related to supplier or quality issues.
  • Championing continuous improvement and value engineering projects for existing products.
  • Providing engineering insights on component obsolescence and product compliance with safety standards.
  • Facilitating change management across product lines and managing Engineering Change Orders.
  • Contributing to the design and testing of new products by offering constructive feedback for manufacturability.
  • Ensuring compliance with FDA design controls and maintaining essential design documentation.

Qualifications:

The ideal candidate will possess:

  • A Bachelor’s degree in electrical, mechanical, systems, or biomedical engineering.
  • A minimum of 5 years of experience in sustaining engineering, particularly within the medical device sector.
  • Expertise in managing component obsolescence challenges.
  • Strong organizational and project management skills.
  • Proficiency in electronics and operating systems, along with MS Office applications.
  • Ability to interpret schematics and electrical engineering documents.
  • Lean Six Sigma certification (Black Belt or Green Belt) is preferred.
  • Familiarity with SMT manufacturing processes and test software platforms.
  • Knowledge of regulatory standards applicable to the medical device industry.
  • Experience with FDA Quality System Regulations and risk management protocols.
  • Understanding of human factors and usability engineering principles for medical devices.

Travel Requirements:

Willingness to travel domestically and internationally as needed, approximately 15% of the time.


Company Overview:

Innova Solutions is a leading provider of technology and business transformation solutions, committed to fostering an inclusive work environment. We prioritize equal employment opportunities and strive to create a workplace free from discrimination.



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