Engr 3, Product Development

13 Nov 2024

Vacancy expired!

Job Description

Engr 3, Product Development

1+ Years Assignment

Tempe,AZOnsite at least 3 days a week. Must be local 3 Must haves on the resume: 1. Knowledge of medical device development and manufacturing 2. Experience in process validation (IQ, OQ and PQ), writing protocols and reports to support verification and validation activities for product commercialization; ability to execute validation 3. Ability to create and execute project plans and ability to lead cross functional teams. Position Summary: This position is a temporary assignment that will support EU-MDR efforts and is anticipated to last approximately through September 2022. Primary focus of this position is to lead EU-MDR submission of products, including product gap assessments, planning and remediation of gaps within project timelines. Successful candidates will assist in developing, optimizing, and validating components/elements of a medical device, write technical documents, validation protocols and reports; prepare work instructions and standard operating procedures; assist in conducting design and process qualification and validation; support test method development and validation, support other activities from R&D, Quality, Operations, and Regulatory Affairs. Essential / Key Job Responsibilities (including supervisory and/or fiscal): 1. Support of EU-MDR submissions: leads all R&D activities surrounding EU-MDR submission of Oncology products, including kits and kit components. 2. Product Remediation: coordinates and/or leads all aspects of product remediation activity related to EU-MDR, including integration of RA, QA/QE, Operations, Clinical, Marketing, Sales and Packaging Engineering. Works with cross-functional teams to remediate gaps related to EU-MDR requirements and meets all deliverables in line with division and business goals. 3. Project Management: creates, tracks and meets project schedules. Creates strategic plans and budgets for EU-MDR projects, assesses and manages priorities and leads task completion to ensure project objectives are met. Coordinates with team members, internal and external suppliers, and outside professionals to ensure project output meet business needs as well as applicable regulatory requirements. 4. Design to Manufacturing Transfer: proposes and facilitates product updates in line with EU-MDR requirements while maintaining design intent and smooth transfer to manufacturing. 5. Documentation: Prepares product development plans, leads and participates in design reviews, approves technical documents and reports. Reviews, approves and coordinates execution of verification and validation protocols and reports. Develops and implements department and division procedures/policy. 6. Test Method Development: leads the development of clinically relevant test methods that adequately challenge product design and processes. 7. Testing: Plan, develop, execute, and manage verification and validation activities for products and processes in support of EU-MDR requirements. 8. Training: train technicians and engineers on design and process development and provide input to training of division procedures and policies. Required Qualifications: • B.S. degree in Mechanical Engineering, Biomedical Engineering, Chemical Engineering, or other related engineering discipline. Biomedical Engineering or Bioengineering Bachelor’s Degree preferred. • Experience: 4-7 years of industrial experience in R&D or process development, preferably in medical device or other regulated FDA/QSR and ISO environment (Masters degree plus 1-3 years medical device or equivalent industry experience). • Demonstrated hands-on technical aptitude. • Experience in process validation (IQ, OQ and PQ), writing protocols and reports to support verification and validation activities for product commercialization; ability to execute validation. • Ability to create and execute project plans. • Ability to lead cross functional teams. • Basic tooling, design and drafting knowledge. • Excellent oral and written communication skills. • Ability to analyze data, interpret results, and write reports. Proficient in statistic software. • Training in Six Sigma or Design for Six Sigma. Preferred Qualifications: • Masters degree in relevant engineering discipline. • Knowledge of cGMP and GLP is a plus. Education and/or Experience: • B.S. degree in Mechanical Engineering, Biomedical Engineering, Chemical Engineering or other related engineering discipline. Biomedical Engineering or Bioengineering Bachelor’s Degree preferred. • Experience: 4-7 years of industrial experience in R&D or process development, preferably in medical device or other regulated FDA/QSR and ISO environment (Masters degree plus 1-3 years medical device or equivalent industry experience).

About Kyyba:Founded in 1998 and headquartered in Farmington Hills, MI, Kyyba has a global presence delivering high-quality resources and top-notch recruiting services, enabling businesses to effectively respond to organizational changes and technological advances.At Kyyba, the overall well-being of our employees and their families is important to us. We are proud of our work culture which embodies our core values; incorporating value, passion, excellence, empowerment, and happiness, creates a vibrant and productive atmosphere. We empower our employees with the resources, incentives, and flexibility that they need to support a healthy, balanced, and fulfilling career by providing many valuable benefits and a balanced compensation structure combined with career development.

Disclaimer:

Kyyba is an Equal Opportunity Employer.

Kyyba does not discriminate on the basis of race, religion, color, sex, gender identity, sexual orientation, age, non-disqualifying physical or mental disability, national origin, veteran status or any other basis covered by appropriate law. Minorities / Females / Protected Veterans / Individuals with Disabilities are encouraged to apply. All employment is decided on the basis of qualifications, merit, and business need.

Rewards:Medical, dental, vision401k Term lifeVoluntary life and disability insuranceOptional Pre-paid legal planOptional Identity theft planOptional Medical and dependent FSAWork-visa sponsorshipOpportunity for advancementLong-term assignment with opportunity for hire by client

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  • ID: #22681043
  • State: Arizona Tempe 85280 Tempe USA
  • City: Tempe
  • Salary: Depends on Experience
  • Job type: Contract
  • Showed: 2021-11-13
  • Deadline: 2021-12-25
  • Category: Legal/paralegal