Catheter Engineer

Location: Minneapolis

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 $,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.