Senior Manufacturing Process Engineer

Thornton Tomasetti; Temecula (CA); Hybrid; USD 78,000 - 156,000; Full time

Benefits offered by this job

Free medical coverage (HIP PPO)

High employer contribution retirement

Tuition reimbursement and FreeU

Job summary

Abbott in Temecula, CA is seeking a Senior Manufacturing Process Engineer to develop and validate manufacturing processes and equipment for vascular devices. The role involves solving complex process problems, executing DOEs and fMEAs, and ensuring adherence to FDA and ISO standards.

The ideal candidate has a mechanical or chemical engineering background, 4+ years of experience, and strong communication skills to work with cross-functional teams in a regulated environment.

Qualifications

• Bachelor's Degree (±16 years) in Engineering/Technical Discipline (Mechanical, Chemical, Electrical or Physics preferred)
• Master's Degree (±18 years)
• Minimum 4 years relevant experience in engineering/manufacturing
• Strong knowledge of design controls and regulations for medical device development (ISO13485, FDA)

Responsibilities

• Specify, design, verify and validate new manufacturing processes and equipment; ensure compliance with medical regulatory standards
• Troubleshoot process equipment and perform process optimization
• Develop process/product specs; conduct pFMEAs, DOEs, validation protocols/reports; document per design control requirements
• Write and submit Engineering Change Orders as needed; maintain quality system effectiveness
• Lead cross-functional teams and participate in design reviews; ensure FDA and ISO compliance

Skills

Mechanical engineering

Chemical engineering

Regulatory compliance

Design controls

Communication skills

Education

Bachelor’s Degree in Engineering

Master’s Degree in Engineering or related field

Job description

## Senior Manufacturing Process EngineerCandidatar-se: United States - California - Temecula: Tempo Integral: Publicado ontem: 31161111Abbott is a global healthcare leader that helps people live more fully at all stages of life. Our portfolio of life-changing technologies spans the spectrum of healthcare, with leading businesses and products in diagnostics, medical devices, nutritionals and branded generic medicines. Our 122,000 colleagues serve people in more than 160 countries.Descritivo de Cargo**Working at Abbott**At Abbott, you can do work that matters, grow, and learn, care for yourself and family, be your true self and live a full life. You’ll also have access to:* Career development with an international company where you can grow the career you dream of.* Employees can qualify for free medical coverage in our Health Investment Plan (HIP) PPO medical plan in the next calendar year.* An excellent retirement savings plan with high employer contribution* Tuition reimbursement, the Freedom 2 Save student debt program and FreeU education benefit - an affordable and convenient path to getting a bachelor’s degree.* A company recognized as a great place to work in dozens of countries around the world and named one of the most admired companies in the world by Fortune.* A company that is recognized as one of the best big companies to work for as well as a best place to work for diversity, working mothers, female executives, and scientists.## ## **The Opportunity**This position works out of our **Temecula, CA** location in the Abbott Vascular Devices division.Abbott Vascular provides innovative, minimally invasive, and cost-effective products for the treatment of vascular disease.Responsible for developing new manufacturing processes, equipment and materials for use in production of medical devices. Works on process engineering problems of diverse scope Exercises judgment and defines methods and criteria in conducting process engineering experiments and reports results Develops networks with internal/external working relationships in area of expertise**What You'll Work On**• Specify, design, verify and validate new manufacturing processes and equipment, in accordance with applicable medical regulatory standards.• Troubleshoots process equipment and perform process optimization.• Develops process/product specifications, conduct pFMEAs, DOEs, validation protocols/reports and other associated documentation following design control requirements.• Communicate effectively and participate on cross functional development teams.• Conducts or participates in technical design reviews for process equipment and product design and requirements documents.• Write and submit Engineering Change Orders, as required.• Responsible for utilizing and maintaining the effectiveness of the quality system.• Development and implementation of new processes, equipment, materials, verification and validation Follow approved Design Control procedures for process development in accordance with FDA guidelines.## **Required Qualifications**Education:Bachelors Degree (± 16 years)Engineering/Technical Discipline (Mechanical, Chemical, Electrical or Physics preferred)An equivalent combination of education and work experienceMasters Degree (± 18 years)IdealExperience:Minimum 4 yearsRelevant experienceSolid knowledge of general Engineering principals.Good knowledge of design controls and regulations for medical device development, (ISO134851, ISO13485, FDA).Strong technical experience in mechanical or chemical engineering with excellent written and verbal communication skills are essential.Strong understanding of processes and materials used in the development and manufacturing of medical devices, particularly diabetes strips.Experience in all of the following: performing complex engineering calculations and relating results to controlled tests, including statistical analysis, tolerance analysis working in a development environment with a disciplined process/product development process.Writing process/product requirements and design specifications.Working on a development team with an emphasis on minimizing time to market.Design for manufacture of low cost, high volume electronic products.Development of processes in an FDA regulated environment with full understanding of GxP, ISO and medical device regulations.Cross functional team environments is required.**Apply Now**Learn more about our health and wellness benefits, which provide the security to help you and your family live full lives: www.abbottbenefits.comFollow your career aspirations to Abbott for diverse opportunities with a company that can help you build your future and live your best life. Abbott is an Equal Opportunity Employer, committed to employee diversity.Connect with us at www.abbott.com, on Facebook at www.facebook.com/Abbott and on Twitter @AbbottNews.**The base pay for this position is**$78,000.00 – $156,000.00In specific locations, the pay range may vary from the range posted.Família de CargoEngineeringDivisãoAVD VascularLocalidadeUnited States > Temecula : Building E - TELocalidades AdicionaisTurno de TrabalhoStandardViagemYes, 5 % of the TimeVigilância médicaYesAtividades de trabalho significativasContinuous sitting for prolonged periods (more than 2 consecutive hours in an 8 hour day), Continuous walking for prolonged periods (more than 2 hours at a time in an 8 hour day), Keyboard use (greater or equal to 50% of the workday)Abbott is an Equal Opportunity Employer of Minorities/Women/Individuals with Disabilities/Protected Veterans.EEO is the Law link - English: http://webstorage.abbott.com/common/External/EEO\\_English.pdfEEO is the Law link - Espanol: http://webstorage.abbott.com/common/External/EEO\\_Spanish.pdf