Process Development Engineer

Join us today and make a difference in people's lives!

LivaNova is a global medical technology company built on nearly five decades of experience and a relentless commitment to improving the lives of patients around the world. Our advanced technologies and breakthrough treatments provide meaningful solutions for the benefit of patients, healthcare professionals, and healthcare systems. The company is listed on the NASDAQ stock exchange under the ticker symbol " LIVN ." LivaNova is headquartered in London (UK) with a presence in over 100 countries and a team of more than 3,000 employees worldwide.

The Process Development Engineer is responsible for developing manufacturing processes to ensure quality product is inventoried per the research and development objectives, product forecast and within agreed budget. The core responsibility is internal manufacturing responsibilities which includes, but not limited to:

• Develops, implements and maintains methods, operation sequence and processes in the manufacture or fabrication of parts, components, sub-assemblies and final assemblies,

• Interfaces with design engineering in coordinating the release of new products,

• Estimates manufacturing cost, determines time standards and makes recommendations for tooling and process requirements of new or existing product lines,

Other responsibilities may include:

• Troubleshooting component and manufacturing processes,

• Lead and execute investigations,

• Perform root cause analysis,

• Weekly conference calls, write and distribute meeting minutes, track and execute assigned tasks

• Guide process development/Design of Experiments (DOE),

• Create, review and approve manufacturing documents (manufacturing process instructions, traveler, router, BOM, inspection plans, deviations, rework procedure, etc.)

• ERP system knowledge,

• Deviation management,

• Non-conformance disposition, justification, risk assessment

• Internal and external training and product supervision,

• Participate in corrective and preventative actions (CAPA)

• Review and approve supplier invoices,

• Define special project scope and objectives, and then execute and report once approved

• Identify material obsolesce and validation new sources,

• Define and implement process improvements,

• Define and implement cost reductions,

• Define and monitor process controls,

• Define and execute process validations (IQ/OQ/PQ)

• Create and maintain product risk analysis (DFMEA and PFMEA)

• Work collaboratively with R&D and Quality engineering

• Travel to supplier locations to monitor manufacturing process and output

• Support supplier audits

TRAVEL REQUIREMENTS: This position may require business travel up to 10% of the time

MINIMUM REQUIREMENTS AND QUALIFICATIONS

• Function independently of direct supervision with independent project management and execution

• BS degree in Mechanical/Electrical/Biomedical/Industrial Engineering

• Experience in a medical device environment

• Thrives in a cross-functional team

• Detail oriented

• Strong problem solving, investigation and root cause analysis skills

• Strong multitasking and organizational skills to be successful in a fast pace dynamic environment.

• Excellent writing, communication, presentation, interpersonal, and teamwork skills

• Ability to communicate technical concepts verbally, graphically, and in written form Experience with Microsoft Office software package, including Word, Excel, and PowerPoint

• Basic statistical analysis knowledge (Statistical Tolerance Intervals, K-factors, T Test, ANOVA, Population definition, Error bars, Histograms, Sample size strategy, etc.)

• Knowledge of various quality system methodologies Lean, 5 Why's, Pareto Analysis, Six Sigma, DFMEA, PFEMA, etc.

• Experience working in a regulated environment (medical, military, aerospace, etc.)

• The minimum requirements, skills and qualifications contained in this job description outline the core functions and requirements of the position and do not constitute an exhaustive listing of activities, duties, or responsibilities that may be required of or assigned to an employee in this position at the Company's discretion.

DESIRED SKILLS AND QUALIFICATIONS

• Experience working for or with contract manufacturer/suppliers therefore understanding the challenges and importance of maintaining a healthy relationship

• Class III medical device (implantable)

• Experience/knowledge about manufacturing processes such as manual assembly, medical device packaging and labeling, resistance spot and laser welding, SMT, adhesive curing, or injection molding and extrusion

• Working experience of project management

• Experience operating in ISO 13485 regulated environment

• Experience with implementation and operation of Lean Sigma concepts and culture

• Experience with establishing product structures, product costs, and/or working with ERP/MRP systems

Pay Transparency: A reasonable estimate of the annual base salary for this position is $75,000 - $85,000 + discretionary annual bonus. Pay ranges may vary by location.

Employee benefits include:

• Health benefits - Medical, Dental, Vision

• Personal and Vacation Time

• Retirement & Savings Plan (401K)

• Employee Stock Purchase Plan

• Training & Education Assistance

• Bonus Referral Program

• Service Awards

• Employee Recognition Program

• Flexible Work Schedules

Valuing different backgrounds:

LivaNova values equality and diversity. We are committed to ensuring that our recruitment process is fair, transparent and free from unlawful discrimination. Our selection process is driven by the key demands/requirements for the role rather than bias or discrimination on the basis of a candidate's sex, gender identity, age, marital status, veteran status, non-job-related disability/handicap or medical condition, family status, sexual orientation, religion, color, ethnicity, race or any other legally protected classification.

Notice to third party agencies:

Please note that we do not accept unsolicited resumes from recruiters or employment agencies. In the absence of a signed Recruitment Services Agreement, we will not consider, or agree to, payment of any referral compensation or recruiter fee. In the event that a recruiter or agency submits a resume or candidate without a previously signed agreement, we explicitly reserve the right to pursue and hire those candidate(s) without any financial obligation to the recruiter or agency.

Beware of Job Scams:

Please beware of potentially fraudulent job postings or suspicious recruiting activity by persons posing as LivaNova recruiters or employees. The scammers may attempt to solicit confidential, personal information, such as a social security number, or your financial information. LivaNova will never ask for fees prior/during/after the application process, nor will we ask for banking details or personal financial information in return for the assurance of employment. If you are concerned that an offer of employment might be a scam or that the recruiter is not legitimate, please verify by searching for "See Open Jobs" on , and check that all recruitment emails come from an @livanova.com email address.