Omnicell, Inc. Design Assurance Engineer in St. Petersburg, Florida
Design Assurance Engineer
Design Assurance Engineer
Omnicell has an exciting opportunity as we look to expand our team adding a Design Assurance Engineer to the Quality Control department. This role will initially focus on expediting technical work related to pharmaceutical packaging equipment. Additional expansion of the role could include support to development engineering, work on piloting manufacturing quality initiatives, review post market design changes/improvements, and product performance post launch.
Review, build and edit technical files and design control documents with integrated hardware and software in accordance with QMS system
Prepare and review design verification test protocols, procedures and reports
Drive risk management activities and updates inclusive of hazard analysis and DFMEAs
Assure all applicable quality decisions are derived from the appropriate risk management document in accordance to the QMS
Facilitate and support potential CAPAs and audits
Providing critical quality review of design requirement rationales, test methods, training requirements and test method validation requirements
Advises and confers with engineers in design review meetings to give part selection, analysis and test recommendations
Participates in supplier quality and capability audits and works closely with suppliers to identify and resolve technical issues that adversely impact quality and reliability of supplier products
Participates in supplier discussions to determine conformance test plans
Participates in a Failure Review Board (FRB) as a team member and technical expert on part construction and failure modes
Participates in root cause analysis investigation as a team member
Supports part-level failure analysis and root cause analysis and working with suppliers/projects to identify corrective action and recovery plans
Works closely with Project Leaders, Electrical/Mechanical Engineers and with other professionals within the project teams
Leading cross functional teams in completing risk assessment and risk management activities.
Working with cross functional teams to complete component qualification activities
Required Knowledge and Skills:
Demonstrated ability to provide statistical guidance in the sampling activities executed for Design Verification
Strongly demonstrated verbal and written communication skills
Ability to identify problems, and develop and implement actions to resolve them
Ability to motivate and influence people to achieve compliance to requirements
Demonstrable track record of project accomplishment
Demonstrable track record of planning activities with contingency actions
Knowledge of component inspection and testing techniques; must be able to read and interpret blueprints
Technical skills in product validation
Team oriented with strong mentoring skills
BS in Engineering
Minimum of five (5) years of experience working with machine development
Experience in product & process development
Proficient with risk management
Minimum five (5) years quality/regulatory experience
Minimum five (5) years design assurance / design quality engineering
Team-centric design experience
Technical resource management
- Travel – 20% Domestic and International
Nothing in this job description restricts management’s right to assign or reassign duties and responsibilities to this job at any time.
All qualified applicants will receive consideration for employment without regard to race, sex, color, religion, sexual orientation, gender identity, national origin, protected veteran status, or on the basis of disability.
Omnicell will not discharge or in any other manner discriminate against employees or applicants because they have inquired about, discussed, or disclosed their own pay or the pay of another employee or applicant. However, employees who have access to the compensation information of other employees or applicants as a part of their essential job functions cannot disclose the pay of other employees or applicants to individuals who do not otherwise have access to compensation information, unless the disclosure is (a) in response to a formal complaint or charge, (b) in furtherance of an investigation, proceeding, hearing, or action, including an investigation conducted by the employer, or (c) consistent with the contractor's legal duty to furnish information.