What are the responsibilities and job description for the Sr. Design Assurance Engineer - Medical Device position at Resolution Medical?
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
Education, Experience, and Required Skills:
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
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
- Statistical and data analysis
- Supervisory, Solid Management and Strong Leadership experience
- 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
- 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.
- 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.
Salary : $120,000 - $150,000