Manufacturing Engineer

Location/Region: New Britain, PA What’s the role? The Manufacturing engineer is responsible for activities that include but are not limited to design, simulation, building, test and documentation to develop and/or maintain or improve production tools and test equipment for the manufacturing of products for ophthalmic surgery. This also includes the development and improvement of production processes and related documentation. All activities need to be carried out in conformity with international regulations, safety and performance standards as applicable. What you’ll do: Provide engineering support to all production sites within the US Update current manufacturing work instructions, drawings, package labeling, and test procedures. Develop process improvements, generate new tooling and fixtures Provide engineering support and expertise in the investigation of nonconformances and CAPA Analyze existing manufacturing processes, identify and implement process improvements. Manage the Preventative Maintenance (PM) system Testing and validating machines with associated processes (FAT, SAT, IQOQPQ) Process documentation and production documents (e.g., Process requirements, SOPS, maintenance plans) Analytically driven, solving (electro)mechanical machine problems Performing machine and process tests and analyzing process data (DOE) Collaboration with external suppliers, system integrators and automation Companies. Preparing risk analyses of assembly and test processes (PFMEA) Training and supervising production personnel and final inspectors in production Continuous improvement of yield and efficiency. BSc./MSc. in mechatronics, mechanical engineering, product design, test‑process‑or industrial engineering or similar. Qualifications Preferred 1–5 years experience in medical device or other regulated industry. Regulations and standards in Medical Devices (e.g., ISO 13485, 21 CFR Part 820) Design and construction of process aids Standard IT skills (Office, Outlook etc.) Problem‑solving techniques (e.g., RCA, DMAIC, 5 Why, Ishikawa, or other) Reporting & documentation skills according to GDP Experience with 2D and 3D CAD (ideally AutoCAD and Solid Works) Process data analysis and specific software (e.g., Minitab) Lean principles, ideally green belt or higher Knowledge of production techniques and market‑available solutions and technologies as well as certification requirements of manufacturing equipment Risk management principles, Process FMEA English: full professional proficiency Team player, trustworthy Ability to communicate transparently & efficiently Ability to manage ambiguity, goal conflicts “Hands on” and “Can do” attitude Actively live and promote DORC Corporate Values Strong analytical skills combined with the capability to see “the big picture” Well organized, goal oriented, high sense of accountability. Benefits 3 weeks of vacation (accrued) 10 sick days annually (prorated for new hires) 10 US holidays 90% of Health Insurance premiums paid by the company. Dental & Vision coverage 401k plan with company match Paid short‑term, long‑term & basic life insurance paid by the company. Bonus program Zeiss provides Equal Employment Opportunity without unlawful regard to an Applicant’s race, color, religion, creed, sex, gender, marital status, age, national origin or ancestry, physical or mental disability, medical condition, military or veteran status, citizen status, sexual orientation, pregnancy (includes childbirth, breastfeeding or related medical condition), genetic predisposition, carrier status, gender expression or identity, including transgender identity, or any other class or characteristic protected by federal, state, or local law of the employee (or the people with whom the employee associates, including relatives and friends). #J-18808-Ljbffr Dormont Manufacturing Co