Manufacturing Engineer(Cleaning & Packaging)

Jiangsu
Permanent
Full-time

2 days ago

Job Description:Determines the optimal manufacturing methods and processes for producing company products from start-up, building the product line, through satisfactory production. This includes analyzing engineering design documents to establish manufacturing methods and processes to manufacture a component, creating conceptual sketches and initiating the design and building of required tooling. Describes outside vendor services needed for the manufacture of a component. Establishes outsourced vendor manufacturing & quality plans. Roles that drive improvement to product cost, quality and performance by utilizing Value Analysis/Value Engineering (VAVE) methodologies should be assigned to this job family. Jobs that provide engineering technical support in this field should be assigned to this job family.Job Requirements:

Solid knowledge of regulatory requirements related to contamination and cleanliness control, or ability to rapidly develop expertise to function independently with minimal supervision.
Familiarity with relevant standards and guidelines:

ISO 13485
ISO 11137-1 & 2
ISO 11737-1, 2, 3
ISO 14644, ISO 14698, ISO 8573
ISO 10993-1

Bachelor’s degree or above in a relevant scientific discipline (preferably in microbiology).
Solid expertise in statistical data analysis.
2+ years of experience in contamination control in the medical device or pharmaceutical industry preferred.
Experience in leading or participating in contamination control projects.
Experience in working with R&D and cross-functional teams.
Experience in implementing and improving cleanliness and contamination control strategies.
Work effectively in a regulated environment, ensuring compliance with quality, safety, and regulatory requirements.
Simultaneously manage multiple improvement projects and ensure timely delivery.
Assess the impact of changes in manufacturing (equipment, process, materials, environment) on contamination and cleanliness control.
Author, revise, and review technical and procedural documentation.
Ability to analyze and solve problems using statistical tools.
Ability to work independently and prioritize tasks in a matrix organization.
Proficiency in English and local language; other languages are a plus.
Familiarity with SAP system.
Strong project management skills.
Excellent communication and interpersonal skills.
Cleanliness and contamination control strategy development.
Analytical and systematic problem-solving.
Collaboration and stakeholder engagement.
Planning and organizing.

Operating Company: Nobel BiocareEnvista and its family of companies (Envista) will not accept unsolicited resumes from any source other than directly from a candidate. Envista will consider unsolicited referrals and/or resumes submitted by vendors such as search firms, staffing agencies, professional recruiters, fee-based referral services and recruiting agencies (Agency) to have been referred by the Agency free of charge and Envista will not pay a fee for any placement resulting from the receipt such unsolicited resumes. An Agency must obtain advance written approval from Envista's internal Talent Acquisition or Human Resources team to submit resumes, and then only in conjunction with a valid fully-executed contract approved by the Global Talent Acquisition leader and in response to a specific job opening. Envista will not pay a fee to any Agency that does not have such agreement and written approval in place.

Envista

Apply Now