Omnicell, Inc. Design Assurance Engineer in St. Petersburg, Florida

Design Assurance Engineer

Description

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.

Responsibilities:

  • 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

Basic Qualifications:

  • 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

Preferred Qualifications:

  • Team-centric design experience

  • Technical resource management

Work Conditions:

  • 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.