Sr Process Development Engineer

Job description

The Opportunity

This position works out of our Santa Clara, CA location in the SH division.

Structural Heart Business Mission: Why We Exist.

Our business purpose is to restore health and improve quality of life by designing and providing device and management solutions for treating structural heart disease.

As the Sr Process Development Engineer, you will serve as the primary engineering personnel supporting manufacturing operations.

The individual performing this role will have strong collaboration with the line supervisor, Quality Engineer and operators to address all the opportunities found in the assigned manufacturing line.

This role will be accountable on quality, output and yield of the assigned manufacturing line.

Will also serve as the engineering management representative in the manufacturing line, executing initiatives and working directly with the DL workforce.

This person may also have a role beyond the line support engineering as a sustaining engineer for the department.

As a Senior Engineer, this person is one of the most experienced and expected to be subject matter expert in the site products and process.

What You’ll Work On

Responsible for assigned line output, safety, yield and quality.

Responsible for identification of product defects and determination of operational and process related actions to reduce the defects.

This may also include equipment trouble-shooting and sub-sequent work order request.

Works with line support team (QC supervisor, Mfg.

Supervisor, Quality Engineer and Operations) to perform on line issue triage to evaluate issues and determine if non-conformance is present, determine initial bracketing and containment, and generate corrective actions/preventative actions as needed.

Responsible for product/process knowledge and understanding of basic cause and effect of line changes.

Considered and expert in statistics, product and Engineering process.

Responsible for modeling/drafting assemblies; fixtures & tools; Solidworks mid to advance level.

Responsible for providing the line with related Engineering fixes, such as tooling (TLTs) and manufacturing aids (from idea definition to implementation).

Knowledgeable of procedures related to equipment controls.

Support technicians and supervisors in equipment availability issues.

Supports Training and Certification Program.

Provides additional insight on how to improve trainings and certifications in the best interest of the business.

Responsible for determining quality impact of Out-of-Tolerance documents.

Responsible for execution of line related change management (material, equipment and process changes).

Responsible for CO and CR generation related to moderate to complex changes impacting the manufacturing line.

Responsible for continuous improvement projects development and execution, including CAPAs implementations.

Responsible for exception subtask execution.

Evaluates ideas for continuous improvements.

Leads root cause analysis efforts for high complexity manufacturing events, utilizing DMAIC model and A3s.

Leads CAPA (Major) investigations with data gathering and analysis as needed.

Owns CAPA activities without oversight.

Runs studies and validations on the line as needed.

Be the ME representative for manufacturing related projects including yield, CIP's, productivity, quality and safety.

Responsible for coordination of product builds through the NPI process.

Generates all types of changes to the eLHR system.

Leads ME support during external and internal audits.

Acts as coach and mentor to more inexperienced engineers or technical personnel.

Leads statistical analysis for complex events at the site.

Can generate qualification and validation protocols and reports with minimal oversight.

Owns basic to medium to high complexity CR activities with no oversight.

Demonstrates comprehensive understanding of regulations in area of work and where to look for information.

Considered SME for most Engineering matters.

In conjunction with RA:
- Understands regulatory implications of proposed changes.
- Understands what types of changes require filings.

Completes documentation to support regulatory filings with oversight.

Minimal oversight required for problems or assignments of reasonable difficulty.

Makes decision in an efficient manner, even when having limited information.

Considers risk mitigation in planning based on lessons learned or from peers.

Reviews previous similar projects and activities as part of the decision-making process.

Anticipates potential situations that may impact projects timeline and resolves them before they become an issue.

Prepares and provides well thought out contribution to meetings.

Provides technical guidance to peers that facilitates the progression of the project, group or person.

Can present information and collaborates with peers across functions (both internally and externally).

Exposure to cross functional mgmt.

communications.

Leads manufacturing engineering projects of high complexity, including CIPs, CAPA, Validations.

May have delegation authority for area manager.

Required Qualifications

Bachelors Degree (± 16 years) in Engineering related field.

Minimum 5 years experience.

Basic knowledge of applicable US non-US applicable regulations.

Knowledge and proficiency in the application and principles of Manufacturing/Process Engineering.

Ability to effectively communicate cross-functionally to assist with resolving Quality/Engineering issues.

Catheter assembly experience is required.

Process Validations experience is required.

Excellent written, verbal and interpersonal communication skills

Ability to interact effectively with all levels of employees.