Advanced Operations Engineer

Job Details

Level
Experienced

Job Location
Phoenix - CC14 - Phoenix, AZ

Remote Type
N/A

Position Type
Full Time

Education Level
4 Year Degree

Salary Range
Undisclosed

Travel Percentage
Negligible

Job Shift
Undisclosed

Job Category
QA - Quality Control

Description

Position Summary

The Advanced Operations Engineer is primarily responsible for supporting new product and process introductions, ensuring that all activities are completed and documented in accordance with cGMPs and relevant regulations and international standards.

Job Responsibilities

The Advanced Operations Engineer is responsible for driving validation and equipment qualification activities, as well as facilitating the transfer of product design into manufacturing processes. The position will work to introduce process improvement methodologies, as well as training other team members in implementation of GMP validation principles.

• Collaborate and assist all departments with equipment validations to achieve and maintain companywide regulatory compliance and operational efficiency.
• Ensure quality of process and product as defined in the appropriate operation and material specifications.
• Will assist in the selection of components and equipment based on analysis of specifications, reliability and regulatory requirements.
• Will analyze equipment to establish operating data, assist in experimental test and result analysis.
• Participate in PFMEA and SOP generation associated with product transfers and launches.
• Assist in establishing Production Part Approval Process (PPAP) and Control Plan methodologies.
• Conduct measurement system analysis studies for new products and new processes as needed.
• Work to introduce and implement process improvement, statistical and problem-solving tools and methodologies.
• Provide training for manufacturing team members.
• Ensure adherence to GMP and safety procedures.

Required Qualifications

• Bachelor's degree in engineering required.
• Good knowledge of manufacturing processes, materials, product and process design.
• Experience in executing complex problem solving techniques related to manufacturing/design technical issues.
• Good understanding of Design for Manufacturing (DFM), related statistical tools and validation/verification techniques highly preferred.
• Demonstrated knowledge of a broad set of improvement and statistical tools/methods used within process excellence activities.
• Demonstrated ability to lead or facilitate projects using DMAIC/Lean methodologies from inception through implementation of recommendations and solutions.
• Conditions of Employment: Individuals must successfully complete pre-employment process, which includes criminal background check, drug screening, and reference verification. Also, individual must be fully vaccinated for COVID-19 by the date of hire to be considered for U.S.-based jobs, if not currently employed by Caris Life Sciences.

Preferred Qualifications

• A minimum of 5 years of experience working within FDA regulated (Medical Device) or regulated industries (Automotive, Aerospace) highly preferred.
• A Black Belt Certification in Six Sigma or Lean-Kaizen or Design for Six Sigma or Operational-Transactional Six Sigma preferred.

Core Skills & Competencies

• Proven ability to drive and develop improvement of critical business metrics.
• Demonstrated organizational, interpersonal, oral and written skills.
• Drive for Results (Service, Quality, and Continuous Improvement) - Ensure procedures and processes are in place that lead to delivery of quality results and continually reassess their effectiveness to achieve continuous improvement.
• Communication - Proficient verbal and written communication skills. Willingness to share and receive information and ideas from all levels of the organization in-order-to achieve the desired results.
• Teamwork - Commitment to the successful achievement of team and organizational goals through a desire to participate with and help other members of the team.
• Customer Service Focus - Demonstrate a focus on listening to and understanding client/customer needs and then delighting the client/customer by exceeding service and quality expectations.

Physical Demands

• Employee may be required to lift routine office supplies and use standard office equipment.
• Ability to sit for extended periods of time.
• Majority of work is performed in a desk/cubicle environment, but at times, may have exposure to high noise levels in the data center, fumes and bio-hazardous material in the lab environment.

Training

• All job specific, safety, and compliance training are assigned based on the job functions associated with this employee.

Other

• This position requires periodic travel and some evenings, weekends and/or Holidays.

This job description reflects management's assignment of essential functions. Nothing in this job description restricts management's right to assign or reassign duties and responsibilities to this job at any time.

Caris Life Sciences is an equal opportunity employer. All qualified applicants will receive consideration for employment without regard to race, religion, color, national origin, gender, gender identity, sexual orientation, age, status as a protected veteran, among other things, or status as a qualified individual with disability.

Qualifications