Job Listing
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| Job ID: 15068868 |
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| Job Location: |
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| How to Apply: | To see employer contact information, log in or register. |
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| Job Title: | Catheter Engineer |
| Work Type: | Work Days: Work Vary: No , Shift: First (Day), Hours Per Week: 40, Work Type: Regular |
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| Salary Offered: | Unspecified |
| Benefits: | Unspecified. |
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| Physical Required: | Unspecified |
| Drug Testing Required: | Unspecified |
| Education Required: | |
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| Experience Required: | Unspecified |
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| Required Skills: | See Job Description section for any required skills. |
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| Job Description: |
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.
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