Business Analyst at Compunnel Inc.

Provides expertise in the optimization of product development.

Title: Principal Manufacturing Engineer (R&D)

Location: Irvine, CA

Duration: 12+ Months

Pay: 85-90 USD/HR

Key Responsibilities:

• Initiate and lead in the improvement, design and optimization of highly complex experiments and tests, analyze results, provide complex recommendations, and develop reports, based on engineering principles that translate to innovative products

• Leverage a robust knowledge of engineering ‘first principles’ to ensure product concepts are viable, functional, and meet performance and cost targets

• Collaborate with clinical and marketing teams to determine project scope, unmet clinical needs, and clinical operational environment – and translate these elements into product performance requirements.

• Assess component, subassembly, and comprehensive product reliability via appropriate statistical tools and methods including sensitivity analysis, Monte Carlo analysis, tolerance stackups.

• Proactively identify issues, achieve resolution, and resolve problems of highly significant complexity on designing parts, components and subsystems

• Validate material selections based on stress and strain encountered, operational environment, biocompatibility requirements.

• Provide direction and guidance on strategies related to technical solution areas

• Provide guidance and design recommendations to enhance manufacturability. Support generation of manufacturing yield and throughput estimations.

• Generate work instructions, test methods, engineering models and drawings/prototypes, etc., to establish/characterize product and/or process specifications

• Oversee R&D support tasks; give instruction to technicians/engineers on conducting tests; train technicians/engineers and provide feedback; and coordinate technician/engineer work.

• May lead cross functional teams through complex design control activities including requirement specs, and risk documents with substantial knowledge on design control requirements

• Develop project plans to assess complex technology and drive project results

• Train, coach, and guide lower level employees on reliability analysis, first principles based design, appropriate material selection, and requirements tracing

• Other incidental duties

Education and Experience:

• Bachelor's Degree in in Engineering or Scientific field , minimum of 8 years years experience of experience, including either industry or industry/education Required or

• Master's Degree or equivalent in in Engineering or Scientific field , minimum of 7 years years experience of experience, including either industry or industry/education Required or

• Ph.D. or equivalent in in Engineering or Scientific field , minimum of 4 years years experience of experience, including either industry or industry/education Required

Additional Skills:

• Proficiency in the usage of relevant computer software

• Excellent documentation and communication skills

• Excellent interpersonal relationship skills including negotiating and relationship management skills

• Recognized as an expert in own area within the organization

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

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

• Expert understanding of processes and equipment used in assigned work

• Strong leadership skills and demonstrated ability to influence change

• Knowledge of and adherence to 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

• Represents organization as key technical contact on contracts and projects

• Interacts with senior external representatives on significant technical matters often requiring coordination between organizations

• Adhere to all company rules and requirements (e.g., pandemic protocols, Environmental Health & Safety rules) 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