Manufacturing Engineer Senior (New Business Development)

Argen Corporation•San Diego, CA

About The Position

The Senior Manufacturing Engineer will contribute to the development, implementation, and maintenance of manufacturing processes to meet company targets for quality, performance, and cost. They will be a subject matter expert and support the activities of the Manufacturing Engineering department to ensure business and customer needs are met. Provides insight to Argen leadership about improving manufacturing processes and efficiency. Help to identify new technologies while driving improvement initiatives, optimize production operations, and foster a collaborative and innovative work environment.

Requirements

Bachelor's degree in Mechanical Engineering, Manufacturing Engineering, Industrial Engineering, or a related field, or equivalent combination of training, education, and experience. Master's degree preferred.
8+ years of experience in manufacturing engineering or related roles within the manufacturing industry, including 3-5 years of people and/or project management experience.
Hands-on experience in high precision machining, automated works cells, and their integration with manufacturing master software.
Proficiency in computer-aided design (CAD) software (Solidworks), manufacturing software tools, and statistical analysis package (MiniTab/JMP).
In-depth knowledge of manufacturing processes, Lean Manufacturing principles, Six Sigma methodologies, and real-time application of process improvements.
Proven ability to lead root cause analysis, problem-solving, and process optimization to improve manufacturing efficiency and quality.
Experience in a hands-on manufacturing environment, with direct involvement in production processes and the ability to work on the manufacturing floor for extended periods.
Strong project management skills, with the ability to manage multiple projects simultaneously and drive new product development.
Advanced knowledge of control procedures, such as Change Management, Standard Operating Procedures (SOPs), and Quality Management Systems (QMS).
Excellent communication and interpersonal skills, with the ability to collaborate effectively with cross-functional teams and senior management.

Nice To Haves

Knowledge of cGMP regulations ISO 13485, 21CFR Part 820, CMDR SOR/98-282, 93/42/EEC, RDC 16 2013, MHLW MO 169 and TG(MD)R Sch3 preferred.

Responsibilities

Maintains operational readiness of manufacturing equipment, works with the manufacturing team to resolve issues, and spends significant time walking and working on the manufacturing floor.
Evaluates manufacturing processes and equipment to identify areas of improvement while actively assisting with production processes.
Engages directly in operations to ensure efficiency, quality, and safety compliance.
Contribute to all aspects of manufacturing engineering including project execution, goal alignment, planning, and mentoring employees.
Manages manufacturing engineering projects including creating project plans, setting milestones, and troubleshooting problems.
Provide guidance, support, and mentoring to ensure professional growth and development of junior team members. Foster a culture of collaboration and innovation within the team.
Identify opportunities for process optimization, efficiency improvements, and cost reduction in manufacturing operations. Lead and support process improvement projects to enhance productivity and product quality.
Collaborate with product development & manufacturing teams to ensure seamless introduction of new products into the manufacturing process. Provide expertise on design for manufacturability and assembly (DFMA) to optimize production processes and assure process capabilities.
Develop and optimize production schedules to meet customer demands and delivery timelines. Coordinate with production supervisors and planners to ensure efficient workflow.
Oversee and be accountable for the development and implementation of manufacturing processes to maintain product functionality and cost efficiency and writes associated SOPs.
Promote and maintain a culture of safety excellence. Ensure compliance with all health and safety regulations and promote continuous improvement in safety practices.
Maintain accurate and up-to-date documentation of manufacturing processes, standard operating procedures (SOPs), work instructions (WIs) and engineering changes. Prepare regular reports on key performance indicators (KPIs) for management review.
Applies engineering knowledge and experience to manufacturing, development, and quality standards for strategic projects.
Develops and improves manufacturing processes including CNC machining, 3D printing, robotics, molding, milling, finishing, cleaning and packaging. Familiarity with Solidworks, AutoDesk, MillBox, and/or other CAD/CAM and CNC type softwares.
Solves complex design and product performance issues to drive continuous improvement as well as new process development.
Manages the writing and execution of test protocols and reports for Installation, Operational and Performance Qualifications (IQ, OQ, PQ).
Reviews, evaluates and implements engineering changes to meet specification requirements.
Ensures continuous improvement of current products and confirms new products meet all company and customer requirements.
Able to delegate tasks when required and help creates and reinforces a culture of teamwork.
Be a subject matter expert in multiple technical areas, exhibiting leadership and mentoring skills, with the ability to inspire and motivate a diverse workforce.
Other duties as assigned.