A large, medical device company in Irvine has an opportunity for a Sr. Level Engineer.
Job Functions- Identify and ensure implementation of opportunities to optimize/improve manufacturing processes including using engineering methods (e.g., SIX Sigma and LEAN methods) employing technical design skills to re-design/design of and ensure equipment, tools, fixtures, etc are up to standards- Develop complex experiments and tests (including writing and executing protocols) to qualify and validate manufacturing processes; analyze results, make recommendations, and develop reports- 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- Lead and establish project plans to ensure deliverables are completed to customer's expectations, using project management tools (e.g., Project Plan, Risk Analysis, etc.)- Oversee manufacturing support tasks; give instruction to technicians on conducting tests; train technicians and provide feedback; and coordinate technician work- Other incidental duties assigned by Leadership 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- May provide guidance to lower level personnel- 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- Direction tends to be high level and focused on end results with means of accomplishment left to incumbent
Skills: 25% of Travel - must be open international TOP SKILLS: -Development Process -Automation/Implementation -Project Management -Design/Assembly/Test Equipment Proven expertise in usage of MS Office Suite including MS Project; CAD experience preferred (if applicable)- Strong documentation, communication (e.g., written and verbal) and interpersonal relationship skills including consultative and relationship management skills- Basic understanding of statistical techniques- Previous experience working with lab/industrial equipment required (if applicable)- Substantial understanding and knowledge of principles, theories, and concepts relevant to Engineering- Strong problem-solving, organizational, analytical and critical thinking skills- Substantial understanding of processes and equipment used in assigned work- Good leadership skills and ability to influence change- Knowledge of applicable FDA regulations for medical device industry- 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 inter-departmental teams and key contact representing the organization on contracts or projects- Adhere to all EHS 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: Bachelor's Degree in Engineering with 4-7 years 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.
Complex Problem Solving