Staff Engineer (Manufacturing)
At a glance
Location: US-CA-Irvine Map
Posted: 09/25/2020
Closing: 10/24/2020
Degree: Not Specified
Type: Contractor
Experience: Not Specified
Job description

• Provides support and oversight of new product development manufacturing engineering for a class III, implantable device for the company's comprehensive portfolio of treatments for structural heart disease within the Surgical BU. 

• This role is accountable for successful completion of post launch deliverables of a new product. The staff Engineer will ensure that design and manufacturing processes are characterized, robust, scalable utilizing best technologies, reflect standard work, are capable and compliant with Regulatory requirements and are validated for Design Control, Manufacturing using LEAN Six Sigma, Design for Manufacturing and Design for Cost Methodologies. The staff Engineer will act as a liaison between R&D, Supplier Development, Quality and Operations team members assigned to the project.

• Responsible for the development of applicable Process Development (IQ/OQ/PQ) protocols and provide support for execution of validation plans and reports

• Drive the development and manage the execution of complex experiments and tests (including writing an executing protocols) on new or existing product lines to qualify and validate manufacturing processes, analyze results, make recommendations, and develop reports

• Drive the development and manage the execution of complex experiments and tests

• Lead and establish complex project plans to ensure deliverables are completed to customer's expectations, using project management tools (e.g., Project Plan, Risk Analysis, etc.)

• Analyze and resolve complex Manufacturing and Compliance issues (e.g., CAPA, non-conformances, audit observations)

• Develop training and documentation materials (e.g., work instructions) for production to enable the seamless knowledge transfer of project and manufacturing processes

Level of Independence:

• Works independently without close supervision

• Compares and evaluates possible courses of action after considering various possibilities

• Applies his or her knowledge in following procedures or in determining which procedures to follow or determining whether specified standards are met

• Considers the cause and effect of activities

• Determines or effectively recommends course of action after considering potential risks of alternatives

• Makes decisions in the face of different alternatives and without formulas or guidelines or with guidelines that are not complete and exhaustive, and which allow room for creativity and judgment


•  Strong communication skills

•  Technical Project Management

•  Work independently

•  Process Development/Validation (IQ/OQ/PQ) - required

•  SOP updates - required

•  Proven track record in design transfers to Operations and process, equipment validation experience

•  Excellent documentation and communication skills and interpersonal relationship skills including negotiating and relationship management skills

• Ability to translate technical information to all levels of the organizations

• Extensive knowledge and understanding of principles, theories, and concepts relevant to Engineering

• Advanced problem-solving, organizational, analytical, and critical thinking skills

• Extensive understanding of processes and equipment used in assigned work

• Strong leadership skills and ability to influence change

• Knowledge of and adherence to corporate Environmental Health and Safety and Quality guidelines as they relate to department clean room medical device manufacturing

• Strict attention to detail

• Ability to interact professionally with all organizational levels

• Ability to manage competing priorities in a fast-paced environment

• Must be able to work in a team environment, including frequent inter-organizational and outside customer contacts

• Represents organization in providing solutions to difficult technical issues associated with specific projects

• Adhere to all corporate rules and requirements and take adequate control measures in preventing injuries to themselves and others as well as to the protection of environment and prevention of pollution under their span of influence/control

Education and Experience:

• Bachelor's Degree in Engineering with a minimum of 4-6 years of experience

We are an equal opportunity employer and make hiring decisions based on merit. Recruitment, hiring, training, and job assignments are made without regard to race, color, national origin, age, ancestry, religion, sex, sexual orientation, gender identity, gender expression, marital status, disability, or any other protected classification. We consider all qualified applicants, including those with criminal histories, in a manner consistent with state and local laws, including the City of Los Angeles' Fair Chance Initiative for Hiring Ordinance.
Staff Engineer (Manufacturing)