Our client, a well-funded startup in the medical device industry, is seeking a talented Process Development/Manufacturing Engineering Manager to join their team in Carlsbad, CA. This dynamic company is dedicated to revolutionizing healthcare through cutting-edge technologies.

Position Overview:

The Process Development/Manufacturing Engineering Manager will spearhead and support new product development initiatives. This role entails the design, development, implementation, and oversight of novel and enhanced manufacturing processes for medical devices. The individual will provide daily support for products, processes, material/supplier management, and equipment for both new and existing products. They will manage production builds and the ramp-up of verification builds through to commercial launch, working within a fast-paced, cross-functional team environment.

Key Responsibilities:

Design and implement new manufacturing processes for both new and existing disposable medical devices.

Collaborate with international suppliers to define and optimize their manufacturing processes, equipment, and tools/fixtures to ensure the delivery of quality products.

Conduct characterization, Design of Experiments (DoE), and perform process/inspection method validation and verification (IQ, OQ, PQ).

Develop comprehensive manufacturing documentation including work instructions, forms, BOMs, routers, FMEAs, DMR, and DHF documents.

Lead a team of engineers and technicians in manufacturing-related activities.

Innovate, design, and develop processes, procedures, tooling, and automation solutions.

Train and mentor direct reports and manufacturing personnel.

Drive initiatives for product/process excellence and technical development.

Develop departmental budgets, schedules/forecasts, and manage resources.

Oversee production builds and process optimization to meet business needs.

Qualifications and Experience:

Bachelors Degree in Engineering, preferably in mechanical or biomedical fields.

Experience in Design for Manufacturing (DFM), Lean Manufacturing, Design of Experiments (DoE), technology/process transfer, product/process failure mode and effects analysis (FMEA), and problem-solving methodologies.

Strong understanding of medical device design controls, quality systems, and product development processes.

A minimum of 8 years of experience in a process/manufacturing engineering role within the medical device industry.

Experience in a regulated environment, ideally within the medical device sector.

Comprehensive knowledge of FDA regulations and the ability to interpret these regulations, guidelines, and policy statements.

Excellent communication skills, both verbal and written.

Strong organizational skills and the ability to implement procedures effectively.

Ideal Candidate:

Highly self-motivated with a collaborative spirit and a determination to achieve set goals.

Experienced in creating and implementing new manufacturing processes and documentation for disposable and/or console medical devices, including but not limited to adhesive bonding, laser bonding, mechanical assemblies, and electrical assemblies.

Proficient in supply chain management and supplier process development/optimization.

Preferred Qualifications:

Six Sigma Certification.

Proficiency in CAD software (e.g., SolidWorks).

Knowledge and/or experience in console assembly and electrical assembly.