Job Description
Job 120 of 500
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1 Job ID:
15068868 Job Location:
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Catheter Engineer
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First (Day), Hours Per Week:
40, Work Type:
Regular Salary Offered:
Unspecified
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Unspecified. Physical Required:
Unspecified
Drug Testing Required:
Unspecified
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Description Job Summary:
The Senior Design Assurance Engineer is a quality engineer that directly supports medical device product development from concept through commercialization working with cross-functional development teams to establish and maintain the design control deliverables, risk management activities, and DHF compliance to ensure delivery of the highest quality product to the customer. Essential Functions:
+ Create and ensure on-time execution of Quality Plans for internal development, OEM-based, Clinical Product Development (CPDP), and design change projects and leading on-time completion of protocols, reports and assigned project deliverables + Accountable for Design Verification and Validation planning and /or, including active cross-functional root-cause analysis investigation & resolution activities + Lead Risk Management activities from product Concept through Commercialization + Support design test and inspection method development, and lead method validation activities + Ensure DHF content integrity, completeness, and regulatory / standards compliance; collaboratively communicating & resolving gaps + Support and ensure internal & external audit responses and on-time product re-certifications + Support and ensure the establishment of objective, measurable, discrete, and verifiable customer, and product requirements + Support and ensure objective component specification definitions, supplied component sampling plan development, and vendor qualifications + Provide support for biocompatibility and sterilization qualifications + Develop and lead other team members and provide work direction as required + May have 2-3 technicians assigned for inspection, testing and project support + Performs other functions as required Requirements Education, Experience, and Required Skills:
+ BS Industrial Engineering, Engineering or Business Degree + 8-15 years of medical device experience in Quality Operations, or equivalent experience + 1-3 years of direct or indirect supervisory experience preferred + Comprehensive understanding of FDA regulations, ISO 13485, ISO 14971 Preferred Skills:
+ Statistical and data analysis + Supervisory, Solid Management and Strong Leadership experience Physical Requirements:
+ Prolonged periods sitting at a desk and working on a computer + Must be able to lift 25 pounds at times + Must have manual dexterity + Must have excellent hand-eye coordination + Must wear gown, gloves, and ear protection if applicable Summary of Benefits + Group health & welfare benefits: Options for Medical, Dental and Vision insurance, Health Savings Account (requires participation in eligible medical plan), and Flexible Spending Accounts. + Company-paid benefits: Employee Life Insurance & Accidental Death & Dismemberment (AD&D), Long Term Disability (LTD), Kavira (requires participation in medical plan). + Voluntary, employee-paid benefits: Employee Supplemental Life & AD&D, Spouse and Dependent Life & AD&D, Short Term Disability (STD), Accident, Critical Illness, and Hospital Indemnity, Employee Assistance Program. + Flexible Time Off Program + Paid Parental Leave + Paid Holidays + Benefits and incentive compensation may be subject to generally applicable eligibility, waiting period, contribution, and other requirements and conditions. Compensation + The typical base pay range for this role is between $120,000-150,000/year. Compensation will vary based on individual job-related knowledge, skills, expertise, and experience. This position is eligible for a discretionary annual incentive program driven by organization and individual performance. + 401(k) Plan:
Company-provided Safe Harbor Contribution of 3% of eligible earnings. Powered by JazzHR Job 120 of 500 Share this:
