Sr Manufacturing Process Engineer (FDA Project)

Research and development, Software, Project planning, Cross-functional, Corrective and preventive action, HPQC, Vbox, Blackbox, Software Verification testing, Medical devices, Software testing, SDP, Supervisory management
Contract W2, Contract Independent, Contract Corp-To-Corp, 12 Months
Depends on Experience
Travel not required

Job Description

Title:  Sr Manufacturing Process Engineer (FDA Project)

Location: Santa Clara, California

Duration: 7 months

Locals Only (Onsite Required)


USC & GC Preferred , consultant must be on our W2


Position Summary from Legacy System

This field includes Main Responsibilities imported from Legacy System.

Responsible for implementing and maintaining the effectiveness of the quality system. Completes professional level engineering assignments related to a specific field or discipline. Leads and participates in projects involving the Design,fabrication,validation,and manufacture of complex instrument subassemblies,systems or processes.




·         Additional Main Responsibilities from Legacy System

·         This field includes Main Responsibilities imported from Legacy System.

·         Performs assignments of a very complicated or difficult nature requiring a high degree of technical competence.

·         Plans,organizes,and conducts technical projects.

·         Consolidates results of design elements of major projects for purpose of design review.

·         Uses engineering principles to conduct technical investigations involved with the modification of material, component,or process specifications and requirements.

·         Conceives and plans projects to explore product or process problems, defines and selects new concepts and approaches to the design or development of new or improved products or processes Applies the results of reviews of literature,patents,and current practices to the solution of current problems.

·         Forms and suggests ideas to support the strategic technical direction of the area,Provide technical guidance to less experienced engineers, designers,and technicians.

·         Formulates detailed plans for execution by other less experienced engineers.

·         Provide input on potential candidates to be hired into the team,Interface with product team members,PCB designers,manufacturing or design engineer,R&D,marketing,regulatory (internal),site engineering,Instrument Development managers,and operations.

·         Synthesizes Proven Approaches: Integrates multiple approaches to solve problems or optimize solutions in complex or cross functional manufacturing processes or product designs.

·         Creates/Modifies Subsystems Designs for Complex Problems: Integrates subsystems and components in total systems designs,develops specifications from customer requirements.

·         Integrates Multiple Project Plans: Establishes and reviews complex plans for multiple activities/ projects or plans highly complex personal projects,monitors and takes corrective action for processes and systems.

·         Translates Regulatory Requirements into Validation Process: Creates efficient protocols for validation of complex system functions and defines validation process.

·         Exchanges Information: Exchanges information with appropriate frequency and within a time frame to maximize its utility and promote cross functional collaboration,verifies that information is understood by the recipient.

·         Adapts Information to Customer Needs: Delivers communications tailored to the needs of the receiver (Managers,peers,customer) Makes Presentations : Defines purpose and objectives,organizes ideas,prepares A-V aids,keeps to time frame and presents intelligibly.,Actively Listens: Listen actively to acquire information and understand the others viewpoint.

·         Give Constructive Feedback: Give appropriate,helpful information specific to the issue,uses examples,ties feedback to specific business issues.

·         Resolves Conflicts: Faces conflicts and takes initiative to resolve them constructively so all parties can be productive,knows when to involve others.

·         Actively Participates in Team Meetings: Actively participates in design review to meet team goals by offering pro and con suggestions,works toward consensus.

·         Shares Resources,Knowledge and Accountability: Shares resources and knowledge,assures the team takes accountability,draws on strengths of each team member.

·         Serves in Multiple Team Roles: Serves as leader,contributor,facilitator,consultant,technical expert,arbitrator,evaluator according to the needs of the team and task.

·         Initiates Decisions: Makes timely and effective decisions,considers alternatives,uses sound judgment,achieves closure on work Confronts Issues: Confronts issues in a constructive manner and at an appropriate organizational level,perseveres in the face of adversity.

·         Motivates Others: Keeps morale high by encouraging others,giving positive feedback and setting a good example,makes and keeps commitments.

·         Receive/Give Performance Feedback: Asks for and gives feedback on the strengths and development needs of self/ others.

·         Identify Future Development Needs: Translates changes in business goals and objectives into the skills,knowledge and experience needed for future work Plans for and Achieves Development: Prepares a plan that sets appropriate development goals,establishes timelines to fulfill development needs,balances the time needed for accomplishing current work and achieving development goals.,Evaluate Risk/Reward Trade Offs: Evaluate risks of alternatives,recommend actions and develop strategies to cope with various scenarios.

·         Provides Input to Strategic Decision Process: Provides input to SDP process that defines the operational strategy for served markets.,Recommends Responses to Technical Trends: Synthesizes technical and customer information to analyze and recommend responses to market and competitive trends,Applies Technology in Innovative Ways: Combines technologies to anticipate or address customer needs,consistently generates/ adopts original solutions to problems and reduces them to practices.


Accountability/Scope/Budget from Legacy System

·         This field includes Accountability/Scope/Budget information imported from Legacy System.

·         Receives general direction,exercises considerable discretion as to personal work details as well as the work details of other technical personnel.

·         Reviews project progress and evaluates results.

·         Reviews,generates,and approves related inputs such as drawings and specifications.

·         Evaluates vendor capabilities to provide required products or services.


Supervisory/Management Responsibilities from Legacy System

·         This field includes Supervisory/Management Responsibilities information imported from Legacy System.

Dice Id : 10450168
Position Id : DYES00004909
Originally Posted : 1 week ago
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