Job Description

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

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.